| HS Code | 605879 |
| Product Name | 3D Systems VisiJet RCL-ENT-D70 Multi-Material Composites (VisiJet CR-CL 200 + VisiJet CE-NT) |
| Material Type | Multi-Material Composite |
| Base Materials | VisiJet CR-CL 200 + VisiJet CE-NT |
| Color | Clear |
As an accredited 3D Systems VisiJet RCL-ENT-D70 Multi-Material Composites (VisiJet CR-CL 200** + VisiJet CE-NT) factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
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VisiJet RCL-ENT-D70 is a dual-stream MultiJet Printing composite generated from VisiJet CR-CL 200** and VisiJet CE-NT. The system produces a Shore D 70 composite under ASTM D2240 after the manufacturer-defined UV post-cure. The rigid phase supplies load-bearing, machinable regions; the elastomeric phase supplies recoverable strain under compressive and tensile loading. No bulk mixing is performed at the user facility: jets from two heated reservoirs deposit the resins in the manufacturer-locked voxel ratio. The uncured resins should be segregated from amine-containing cleaning agents and strong bases, because nucleophilic contaminants can disturb acrylate polymerisation and produce tacky uncured zones. Cartridges moved from cold storage into an environment above 60% RH should be equilibrated until surface condensation clears before loading; water droplets at the jetting face are a documented source of intermittent void formation.
In sinonasal tumor resection planning, patient-specific models are produced by segmenting high-resolution CT data sets with a slice interval of 0.6 mm or finer; the segmented volume is converted into a watertight STL file for MultiJet Printing. The CR-CL 200** stream is assigned to the lamina papyracea, ethmoid labyrinth, maxillary sinus walls, and pterygopalatine fossa, while the CE-NT stream is assigned to middle turbinate mucosa, nasal soft tissue, and periorbital fat analogues. The build orientation is selected to reduce support wax entrapment within the frontal recess and sphenoethmoidal recess; retained wax in these sub-millimetre channels is the primary batch rejection cause when soak times fall below the manufacturer-defined interval. The resin delivery ratio is not user-editable and is maintained by the printer to yield the Shore D 70 composite under ASTM D2240; no solvent dilution or third-party flexibiliser is permitted because altering the voxel-level ratio produces regional hardness drift. Downstream production uses a heated planarizer that levels both photopolymer phases after each jetting pass, followed by a two-stage support removal protocol: bulk wax removal in an ultrasonic bath at 38–40 kHz, then a clean isopropanol rinse. Post-cure is carried out in a UV flood chamber with primary emission between 365 nm and 405 nm until dimensional stability is reached. Finished parts include endoscopic sinus surgery rehearsal models, skull base approach simulation models, and multidisciplinary tumor board reference models. In hospital quality systems, these parts are controlled under ISO 13485:2016 clause 7.5.2; they are not implantable devices and are not supplied sterile for patient contact beyond brief glove handling.
Temporal bone dissection models built from the RCL-ENT-D70 composite are used to train drilling of the mastoid cortex, facial recess, and labyrinthine bone. Under high-speed otologic burrs operating between 40,000 min⁻¹ and 75,000 min⁻¹, the CR-CL 200** phase produces brittle chip fragments analogous to cortical bone, while the CE-NT phase dissipates energy at the sigmoid sinus and dura analogue interfaces and prevents catastrophic crack propagation across the tegmen plate. The two resins are maintained at the factory-set voxel ratio for Shore D 70; a lower CE-NT fraction reduces tear resistance of thin partitions, while a higher fraction shifts the durometer below the ASTM D2240 Type D 70 target and alters burr feed behaviour. The production workflow uses MultiJet Printing with a heated planarizer, wax supports, and ultrasonic wax removal in heated isopropanol at a bath temperature not exceeding 40 °C to avoid swelling the elastomeric phase; full UV post-cure is mandatory because uncured CE-NT domains smear and clog burr flutes. Finished parts include mastoidectomy training blocks, posterior tympanotomy drilling models, and translabyrinthine approach simulation parts. The most frequent production failure is interface delamination between the two resin phases when thin bony membranes are subjected to repeated burr passes; published data for the exact fatigue limit of this interface is limited, so wall thicknesses should follow the minimum shell threshold set in the printer’s build preparation software. ASTM F2503 assessment is the end user’s obligation if the part enters an MR suite; the composite is not steam-sterilisable, and autoclave exposure is not validated.
| Compliance boundary | Standard or regulation | Scope |
|---|---|---|
| Shore hardness verification | ASTM D2240 | Type D durometer check on post-cured composite; applies to all finished parts. |
| Production control for patient-specific parts | ISO 13485:2016 clause 7.5.2 | Lot traceability, process validation, and QMS control in certified facilities. |
| Design controls for finished test fixtures | FDA 21 CFR 820.30 | Applies only when the model is integrated into a medical device manufacturer’s test or surgical planning system. |
| MR suite entrance | ASTM F2503 | End-user responsibility; the composite must be assessed for the intended field before use. |
| Chemical product supply in EU | REACH 1907/2006 Annex II | SDS content and risk management measures for resin cartridges supplied into the EU. |
For bench testing of airway stents and bronchoscopic instruments, rigid laryngotracheal frames are combined with elastomeric intercartilaginous membranes in one piece. The CR-CL 200** stream represents cricoid and tracheal cartilage rings, while the CE-NT stream represents annular ligaments and subglottic soft-tissue compliance. The two formulations are metered from independent MJP material bays at the manufacturer-defined ratio for a Shore D 70 composite; manual mixing is thermally unstable because the viscosity difference between the two streams can cause phase separation before UV cure. The build file orients the tracheal lumen vertically to reduce support wax pooling at the carina; residual wax is removed in an ultrasonic bath operating between 38 kHz and 40 kHz, followed by a secondary isopropanol rinse. UV post-cure uses lamp output between 365 nm and 405 nm, and the lumen is checked with plug gauges or a disposable endotracheal tube. Terminal products include tracheobronchial tree models for stent deployment testing, tracheostomy care trainers, and pediatric airway endoscopy simulators. FDA 21 CFR 820.30 design controls apply only when the model is integrated into a device manufacturer’s finished test fixture; otherwise, the model is an evaluation aid and not a medical device. The composite is not rated for prolonged mucosal contact or implant use, and no ISO 10993 biological evaluation is transferred automatically to the finished model.
Craniomaxillofacial teams use the composite to evaluate saw guide seating on patient-specific maxillary and mandibular models before an osteotomy is performed. The CR-CL 200** phase provides cortical bone-like resistance during reciprocating saw contact, and the CE-NT phase allows simulated periosteal and gingival displacement without surface tearing. Shore D 70 is the acceptance criterion and is verified on each lot under ASTM D2240; any deviation outside the manufacturer’s accepted tolerance requires quarantine because saw guide drift becomes detectable during oscillation. The MJP build recipe combines the two resins at the manufacturer-fixed voxel ratio; there is no bulk addition ratio in the conventional compounding sense, and only the print software controls the transition zones between rigid and elastomeric domains. Processing uses a planarized MultiJet system with wax supports; support removal for parts with a palatal vault thickness greater than 2.0 mm is performed in an ultrasonic bath at 38–40 kHz with heated isopropanol, and the soak duration follows the resin manufacturer’s protocol. Post-curing is completed in a UV chamber with primary emission at 365 nm until the composite reaches dimensional stability. Terminal parts include Le Fort I segment movement models, mandibular split simulation models, and custom saw guide verification fixtures. ISO 13485:2016 clause 7.5.2 governs lot traceability and process validation where the part is supplied by a certified manufacturer. The composite is not cleared as an implant or intraoral splint and must not be left in contact with open surgical sites.
Within otolaryngology residency programs, composite laryngoscopy and septoplasty trainers are built with the rigid nasal septum and turbinate structures in CR-CL 200** and the compliant nasal valve sidewalls in CE-NT at the standard Shore D 70 voxel ratio; no user-formulated ratio changes are permitted. Support wax is removed in an ultrasonic isopropanol bath, and parts are UV post-cured to the defined durometer under ASTM D2240. Finished trainers include cricothyrotomy mannequins, flexible nasolaryngoscopy training heads, and septoplasty airway models. These models are non-patient-contacting teaching aids; they are not medical devices under FDA 21 CFR §860.7 unless surgical claims are appended. Lot-to-lot hardness variation is controlled by Shore durometer checks, but no published standard for repeated instrument insertion fatigue exists for this specific composite.
Reference phantoms made from the composite are used to register optical or electromagnetic tracking systems to preoperative imaging coordinates. The CR-CL 200** phase is machined to accept ceramic fiducial spheres, while the CE-NT phase provides non-slip contacting surfaces for reference frame clamps. Dimensional drift between the printed part and the source CT volume is measured on a coordinate measuring machine; the acceptance criterion for the full phantom body is set by the end user’s navigation system accuracy, and published data for this composite in navigation phantoms is limited. The two resins remain at the manufacturer-fixed voxel ratio for Shore D 70; no offline blending is permitted. The production sequence includes MJP planarization, wax support removal in an ultrasonic isopropanol bath at 38–40 kHz, and UV post-cure between 365 nm and 405 nm. Because the photopolymer is not inherently radiopaque at diagnostic CT energies, fiducial markers are embedded in the rigid phase after printing; the CE-NT domains provide low-signal boundary contrast in the phantom. Terminal products include surgical navigation verification phantoms, CT registration jigs, and optical tracking fixtures. ASTM F2503 testing is the end user’s responsibility if the phantom enters the MR suite; ISO 13485:2016 clause 7.5.2 applies to traceability when the phantom is supplied as a controlled production part.
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3D Systems VisiJet RCL-ENT-D70 Multi-Material Composites is a dual-resin material-jetting configuration in which rigid clear domains are generated from VisiJet CR-CL 200** and elastomeric domains are generated from VisiJet CE-NT. The RCL-ENT designation identifies the presence of a rigid clear phase and an elastomeric natural phase, while the D70 suffix identifies the target durometer of the elastomeric solid after post-cure as 70 Shore A. The system is processed on MultiJet Printing platforms equipped for simultaneous delivery of two photopolymer build materials and a sacrificial wax support. The rigid component contributes dimensional stability and load-bearing capacity, and the elastomeric component contributes compressive recovery, sealing compliance, and soft-touch surfaces in one build cycle without adhesive bonding or secondary overmolding.
The paired build style is specified for functional prototypes and short-run production of housings with integral gaskets, fluidic manifolds with soft pinch valves, overmolded grips on rigid cores, and vibration-isolating mounts. In these applications the transition between the two phases is printed as a discrete or graded interface according to job setup. Interface orientation relative to the z-axis influences peel resistance and fatigue behavior. Published data for the interfacial bond strength of RCL-ENT-D70 as a paired system is limited; users should generate application-specific peel, pressure-decay, and thermal-cycling data using the current material technical bulletin for the constituent resins.
Equipment compatibility for RCL-ENT-D70 is constrained by the requirement for two independent build-material delivery channels, heated recoater or non-contact planing, and wax-support removal capacity. The host MultiJet Printing platform must maintain stable jetting viscosity and surface tension for both photopolymers across the duration of the build. MJP-grade photopolymers of this class are typically maintained in the printhead at a viscosity range of 10 mPa·s to 15 mPa·s, but lot-specific values for the VisiJet pair must be confirmed against the current safety data sheet and material technical bulletin. The build chamber temperature and layer-thickness profile are selected to balance interlayer wetting between the chemically dissimilar phases.
The two constituent resins differ in crosslink density and volumetric shrinkage. The rigid CR-CL 200** phase develops a glassy polymer network with comparatively low chain mobility, whereas the CE-NT phase retains viscoelastic response after UV curing. If both phases are polymerized simultaneously in the same layer, the shrinkage mismatch creates a stress concentration at the transition boundary. The print strategy available on the host MJP system controls the order of phase deposition and UV exposure so that shrinkage is not permitted to accumulate across large continuous interfaces. Tensile and flexural test specimens should be oriented so the interface lies along the loading axis when measuring constituent strength, and perpendicular when measuring cleavage resistance. A standard tensile test such as ASTM D638-14 on the rigid phase and ASTM D412-16 on the elastomeric phase provides constituent-level comparisons, but it does not by itself measure the interfacial strength of the multi-material body.
Residual stress in multi-material MJP parts is relieved partially by the post-cure thermal cycle. The elastomeric phase may continue to crosslink with time, producing an increase in Shore A hardness and a corresponding reduction in elongation. Parts with thick rigid cores and thin elastomeric skins can exhibit distortion after support removal because the rigid phase restricts the shrinkage of the elastomer. The resulting strain is non-uniform and is best mapped by digital image correlation across the transition boundary rather than by point-wise strain gauges. Interfacial debonding tends to initiate at sharp corners where the local stress exceeds the adhesion strength of the co-jetted interlayer.
In-process control of the rcl-ent-d70 build interface is further influenced by z-axis print resolution. Finer layer thickness values reduce the visible stair-step effect at the transition boundary but increase build time and may increase the number of material transitions per unit height. Coarser layer thickness values reduce print time but create larger discrete steps that act as mechanical stress risers when the part is loaded perpendicular to the interface. Process qualification should include a design-of-experiments matrix across two or three layer-thickness profiles to correlate surface finish, interface strength, and dimensional capability for the intended part geometry.
Replacing multicomponent assembly with a single multi-material print changes the tolerance stack. In a printed elastomer seal, the compression set under load determines whether the seal remains effective after thermal cycling. Users evaluating RCL-ENT-D70 for sealing should quantify compression set according to ASTM D395-18 under the intended service temperature and fluid environment. The rigid clear phase is generally resistant to the mineral-oil and wax-based support-removal processes used in MJP; the elastomeric phase may absorb a small quantity of support-removal solvent if the part is exposed above the recommended wash temperature. Washing in heated solvent can swell the elastomer by a measurable amount and delay dimensional recovery for several hours after drying. Dimensional inspection should therefore occur after post-cure and after a stabilization period at 23 °C ± 2 °C and 50% ± 5% RH.
Support wax removal for dual-material MJP builds is commonly performed in a stirred heated bath. The removal rate is temperature-dependent; raising the bath temperature accelerates dissolution but also expands the elastomer phase and can create microcracks at the transition boundary if the rigid phase is still brittle before post-cure. The recommended sequence is to remove bulk wax below the softening threshold of the CE-NT phase, then re-cure both phases uniformly. If oven post-curing is performed before complete wax evacuation, the remaining wax can permeate the porous near-surface layer of the elastomer, producing a hazy residue that cannot be fully removed by solvent washing.
Dimensional accuracy in the z-direction is more sensitive to support-removal duration than xy-plane dimensions because the wax layer between the build tray and part controls the bottom surface flatness. Extended solvent exposure at the beginning of part life can reduce the stiffness of the elastomeric phase and shift the apparent Shore A reading by several points until the solvent has fully evaporated. For this reason, compressive-seal testing immediately after support removal is not representative. A conditioning period of at least 24 h at ambient conditions is often necessary before mechanical testing, with longer periods required for thick sections or high-surface-area elastomeric geometries.
Post-cure uniformity across the rigid-elastomer boundary is required to prevent localized under-crosslinking in the CE-NT phase. UV post-cure chambers with broad-spectrum output and controlled temperature are preferred over narrow-wavelength handheld units. The rigid phase may shield the elastomeric transition zone from light if the part is oriented with a large rigid overhang covering the soft feature. In such cases, dose mapping or multiple post-cure orientations are used to expose the concealed elastomer surfaces. The host platform’s recommended post-cure dose should be verified for thick multi-material sections; under-cured CE-NT domains exhibit tacky surfaces, increased compression set, and reduced resistance to solvent ingress.
The service window of the CE-NT phase is bounded by low-temperature stiffening and high-temperature stress relaxation. At temperatures below 0 °C, the elastomer durometer increases and the material may no longer recover from 25% compressive strain without permanent set. At temperatures above 50 °C, the load-bearing contribution of the elastomer drops, and the transition interface may become the controlling failure site if the part is under tensile peel. For continuous load-bearing applications, the rigid CR-CL 200** phase should carry the mechanical load; the CE-NT phase should be considered a compliance or sealing feature. Thermal expansion mismatch between rigid and elastomer phases is measured by coefficient of linear thermal expansion; if the part spans more than 100 mm, the differential expansion may alter seal preload and should be included in the tolerance analysis.
Fluid compatibility must be evaluated when the elastomer phase is used in sealing applications. Cellulose-derived or polar solvents may extract unreacted photoinitiator residues and shift the durometer or surface energy of the CE-NT surface. The rigid phase is generally less sensitive to solvent uptake but may craze under repeated contact with ketone-based cleaning agents. Users should implement chemical exposure testing according to ASTM D471-16 for elastomer swelling and ASTM D543-21 for rigid-polymer resistance, with the test fluid selected to match the intended operating environment. Published compatibility data for the RCL-ENT-D70 paired system is limited; single-material resistance cannot be assumed to reflect the multi-material interphase.
| Property | Test standard | VisiJet CR-CL 200** rigid phase | VisiJet CE-NT elastomer phase |
|---|---|---|---|
| Tensile strength | ASTM D638-14 | 35–48 MPa | — |
| Tensile strength | ASTM D412-16 | — | 1.5–3.5 MPa |
| Tensile modulus | ASTM D638-14 | 1.4–1.8 GPa | — |
| Elongation at break | ASTM D638-14 | 15–25% | — |
| Elongation at break | ASTM D412-16 | — | 180–250% |
| Durometer | ASTM D2240-15 | — | 70 Shore A target |
| Flexural strength | ASTM D790-17 | 50–65 MPa | — |
Ranges shown in Table 1 are representative of separately published constituent-resin data and should not be used as lot-release limits for the paired RCL-ENT-D70 composite. Orientation, layer thickness, interface geometry, and post-cure dose produce observable shifts in the final component properties. A paired-system test plan should include tensile bars machined from the multi-material build in the intended print orientation rather than only testing the individual resins in isolation.
In comparison with single-material VisiJet CE-NT builds, RCL-ENT-D70 removes the need to solvent-bond or mechanically fasten elastomeric components to rigid structural parts. In comparison with single-material VisiJet CR-CL 200** builds, it adds compressible sealing function at the expense of full optical clarity and homogeneous refractive index. The system differs from conventional two-shot injection molding because the part is built layerwise without mold tooling, but the co-printed interface is generally not as cohesive as a chemical bond formed during overmolding. Users requiring repeated tensile cleavage across the interface should regard the transition boundary as a mechanical interlock system rather than a fused molecular network. Selection of RCL-ENT-D70 over separate single-material prints is therefore driven by part-count reduction and geometric integration, not by isotropic mechanical equivalence.
| Factor | RCL-ENT-D70 | Single-material CE-NT | Single-material CR-CL 200** |
|---|---|---|---|
| Integral rigid-load path | Present | Absent | Present |
| Integral elastomeric compliance | Present | Present | Absent |
| Adhesive bond line | Not required | Required for rigid assembly | Not applicable |
| Optical homogeneity | Reduced at transition | Not applicable | High in clear regions |
| Wax removal sensitivity | Higher near elastomer domains | Higher due to full elastomer surface | Lower |
| Build-time penalty | Moderate dual-material transition time | Lower than paired material | Lower than paired material |
When dimensional tolerance requires a rigid reference plane and a soft sealing bead, the multi-material configuration is preferable to assembling a separately printed elastomer gasket into a rigid housing. The primary operational boundary is the interphase itself: peel-dominated loads, aggressive solvent exposure, and repeated thermal shock can reduce the lifetime of the transition region before the bulk phases reach their individual limits. Testing at the intended service temperature, with the intended fluid and load cycle, is required because published data for this specific configuration is limited beyond the constituent-level property ranges and platform processing recommendations.
