| HS Code | 774252 |
| Product Name | Proto3000 Formlabs Custom Tray Resin |
| Distributor | Proto3000 |
| Manufacturer | Formlabs |
| Material Type | Photopolymer resin |
| Color | Clear |
| Volume | 1 L |
| Compatible Printers | Formlabs Form 2, Form 3, Form 3B, Form 3B+, Form 3BL |
| Biocompatibility | Class I biocompatible |
| Intended Applications | Custom impression trays and orthodontic appliances |
| Layer Thickness | 100 microns |
| Curing Wavelength | 405 nm |
| Storage Conditions | Store at 18-28 °C, away from direct sunlight |
| Shelf Life | 1 year |
As an accredited Proto3000 Formlabs Custom Tray Resin factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | The Proto3000 Formlabs Custom Tray Resin is packaged in a sealed 1 L cartridge with safety labels and handling instructions. |
| Container Loading (20′ FCL) | Proto3000 Formlabs Custom Tray Resin is loaded in a 20′ FCL, palletized, secured, and braced for safe ocean transport. |
| Shipping | Proto3000 Formlabs Custom Tray Resin is non-regulated for transport. It ships in sealed Formlabs cartridges or bottles with an SDS included. Standard ground or air service is permitted; no hazmat placards or fees typically apply. Store upright, away from heat, and inspect for leaks upon delivery. |
| Storage | Store Proto3000 Formlabs Custom Tray Resin in its original, tightly closed, opaque container, upright, in a cool, dry, well-ventilated area. Keep away from direct sunlight, UV light, heat, sparks, and incompatible materials. Maintain 18–28°C (65–82°F); do not freeze. Protect from moisture and damage. Keep out of reach of children and follow the SDS. Reseal after use and observe shelf-life limits. |
| Shelf Life | Shelf life is 12 months from date of manufacture when stored sealed, upright, at 18–28°C, away from direct sunlight. |
Partially dentate fixed prosthodontic cases generate the highest volume of custom tray production when digital impression data from an intraoral scanner must be converted into a rigid elastomer-carrier within a dental laboratory. In this application, Proto3000 Formlabs Custom Tray Resin is charged into the vat at 100% v/v as supplied, with no additional methacrylate diluent or filler, because the formulated rheology is matched to the recoating behavior of Formlabs 405 nm low-force stereolithography systems operating with an 85 µm laser spot and a resin temperature equilibrated to 22°C–25°C before the build. The tray body is designed with a basal thickness of 2.0 mm, occlusal stop thickness of 1.5 mm, and a peripheral border extension that follows the mucobuccal fold without exceeding 1.0 mm distance from vestibular soft tissue in the digital model. Manufacturing on a Form 3B or Form 3BL uses 50 µm layer height for occlusal stops and 100 µm for bulk flange and body sections, with the intaglio surface oriented 30°–45° from the build-platform normal to reduce stair-step indices on tissue-facing stops. After completion, the tray is washed in two separate ≥99% isopropyl alcohol baths for 10 minutes per bath under agitation, blown free of solvent with compressed air for 5 minutes, and post-cured in a 405 nm LED chamber at 60°C for 30 minutes. The terminal article is a single-use custom impression tray for quadrant and full-arch crown and bridge impressions; the resin is evaluated under ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 for biological endpoints and is processed under laboratory documentation consistent with ISO 13485:2016 and FDA 21 CFR Part 820, but it is not indicated for overnight intraoral use or as a final prosthetic substrate.
| Standard / regulation | Document scope | Application in tray production |
|---|---|---|
| ISO 10993-1:2018 | Biological evaluation planning for medical devices | Defines biological endpoint selection for a transient mucosal contact tray |
| ISO 10993-5:2009 | In vitro cytotoxicity testing | Assesses leachable response from post-cured resin before clinical release |
| ISO 10993-10:2010 | Irritation and delayed-type hypersensitivity | Supports short-term intraoral contact documentation for disposable trays |
| ISO 13485:2016 | Quality management systems for medical devices | Controls CAD, printing, washing, post-cure, and packing traceability |
| FDA 21 CFR Part 820 | Quality system regulation | Controls device master records, complaint handling, and batch release in U.S. distribution |
Because full-arch edentulous impression trays fabricated from Proto3000 Formlabs Custom Tray Resin introduce a dimensional conflict between finer layer resolution and build time on Form 3BL equipment with a 33.5 × 20.0 × 30.0 cm build volume, the choice of layer height is driven by flange length and border geometry rather than by surface texture alone. The resin is processed at 100% v/v as-received, and the absence of solvent means that green-state strength depends on the degree of conversion accumulated layer by layer rather than on evaporative film formation; however, printed tray flanges longer than 60 mm can exhibit marginal curl when printed at 50 µm if the chamber temperature deviates by more than ±2°C from the resin conditioning temperature. Published data for this specific configuration is limited, but production records from dental service laboratories using Form 3BL platforms indicate that switching to 100 µm for the tray base and posterior flange reduces the incidence of platform-side dimensional drift during sequential layer recoating. The downstream process for this segment begins with CAD design of a full-arch tray with a 3.0 mm base, 1.5 mm anterior flange, 2.5 mm posterior border bead, and 1.5 mm drainage perforations placed 4 mm apart in nonfunctional zones; orientation angles for the anterior flange are held between 20° and 35° from vertical to preserve border sharpness. After printing, the tray is washed in two ≥99% isopropyl alcohol baths for 10 minutes each, air-dried until tray mass stabilizes to within 0.1 g between successive readings in a 23°C forced-air environment, and post-cured at 60°C for 30 minutes. The terminal product is a rigid full-arch custom tray for mucostatic or mucocompressive denture impressions, and the compliance documentation references ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 13485:2016 as clinical and manufacturing controls.
| Parameter | 50 µm regime | 100 µm regime | Control limit / note |
|---|---|---|---|
| Layer thickness | 50 µm | 100 µm | ±2 µm after platform calibration |
| Wash solvent | ≥99% isopropanol | ≥99% isopropanol | Replace when water content exceeds 5% v/v |
| Wash time per bath | 10 min | 10 min | Extend to 15 min if bath temperature <18°C |
| Drying | 5 min compressed air | 5 min compressed air | No residual solvent film in perforations |
| Post-cure temperature | 60°C | 60°C | ±3°C for dimensional control |
| Post-cure time | 30 min | 30 min | No release if total post-cure is <20 min |
In open-tray implant impressions for multi-unit screw-retained prostheses, access windows through the tray body must be structurally isolated from the flexible flange regions. Proto3000 Formlabs Custom Tray Resin is employed at 100% v/v as-received; adding particulate filler or thickening agent is prohibited because an increase in viscosity beyond the formulated range raises vat film separation forces and can detach thin 1.5 mm access-channel walls during the peel step of 405 nm low-force stereolithography recoating. The digital design for this segment incorporates access windows with 5.0 mm–6.0 mm internal diameter around each screw-access channel, stiffening ribs of 1.5 mm–2.0 mm width at 45°–60° to the long axis, and a tray body thickness of 2.5 mm over edentulous ridges; the resin is printed at 100 µm layer height to maintain lateral wall integrity across the full tray height. Manufacturing proceeds from an intraoral scan or stone master with implant analog positions, followed by printing on Form 3B or Form 3BL, a two-stage wash in ≥99% isopropyl alcohol for 10 minutes per bath, compressed air drying, and post-cure at 60°C for 30 minutes. After post-cure, open-tray implant impression copings are verified to protrude 1.0 mm–1.5 mm above the resin access window, and the terminal product is an open-tray custom impression tray for multi-unit implant cases, controlled under ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 13485:2016; the tray is not designed for closed-tray pickup impressions or for loading with high-viscosity polyether materials unless the access-channel clearance is revalidated.
For dental service bureaus transitioning from analog custom tray fabrication to 405 nm low-force stereolithography, the risk profile shifts from single-tray accuracy to inter-tray consistency across a 24-tray build platform on Form 3BL equipment. In this production segment, Proto3000 Formlabs Custom Tray Resin is introduced into the vat at 100% v/v as-received, and the vat is not topped off with different lots without recertifying the lot blend because photoinitiator concentration may vary across batches within the manufacturer’s specified lot tolerance. The manufacturing process nests multiple tray files with 4 mm separation, rotates each tray 35° around the vertical axis to distribute peel forces, and uses a layer thickness of 100 µm for all tray bodies except for thin 1.5 mm occlusal stops, which may be maintained at 50 µm on a case-by-case basis. After printing, the build platform is placed in a programmable two-bath washing station with ≥99% isopropyl alcohol for 10 minutes per bath, and each tray is blown dry with filtered compressed air for 5 minutes before post-curing at 60°C for 30 minutes in a 405 nm LED chamber. Dimensional verification uses a calibrated dental laser scanner or coordinate measuring machine to compare the printed intaglio surface to the CAD reference, with a maximum allowable dimensional deviation of 0.10 mm on occlusal stops and 0.20 mm on peripheral flange borders. The terminal articles are custom impression trays distributed to multiple clinics, and the service bureau’s quality system references ISO 13485:2016, FDA 21 CFR Part 820, ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 for biocompatibility documentation; trays are not released if solvent odor remains at the time of packaging or if post-cure shrinkage produces an occlusal stop deviation exceeding 0.10 mm.
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Proto3000 Formlabs Custom Tray Resin is supplied through Proto3000 as a cartridged 405 nm photopolymer for Formlabs dental stereolithography platforms. The Formlabs material designation is Custom Tray Resin, and its intended output is the additively manufactured custom impression tray or tray base. The resin is methacrylate-based and is cured by the printer light source in a layerwise pattern. Unlike thermoformed tray blanks or hand-mixed powder-liquid acrylics, this product is used after digital tray design and is subject to printer-managed exposure, lift, and support settings. The cartridge format eliminates manual weighing and mixing but requires compatible equipment and dedicated processing accessories. Operators should confirm the regional Proto3000 part number and the compatible printer generation because cartridge part numbers vary by region and revision. Mechanical property datasheets for cured specimens are generated using ASTM D638 and ASTM D790; current lot-specific values are available in the Formlabs material datasheet and should be used for engineering verification.
The sealed cartridge should be stored at 10–30 °C in a dark, dry location. The cartridge should be inverted several times before loading to redisperse any settled components; solvent addition is contraindicated. The resin tank, build platform, and wiper are dedicated to Custom Tray Resin to reduce cross-contamination. Work area controls include nitrile gloves, safety glasses, and local exhaust ventilation. Uncured resin spills are cured under UV or ambient light before cleanup. The material is an irritant in the liquid state; contact with skin and eyes should be managed according to the safety data sheet.
For digital tray design, the dental model is blocked out in areas that would lock the tray onto undercuts, and a relief of 2.0–3.0 mm is applied over the alveolar ridge to create space for impression material. Medium-viscosity polyvinyl siloxane typically requires less relief than high-viscosity putty systems; the exact offset is set in the CAD software before the tray shell is generated. The tray floor is commonly designed at 1.5–2.0 mm thickness, with borders thickened to 2.5–3.0 mm to resist flexure during insertion. Three or more tissue stops, printed monolithically, are positioned to produce a controlled stop on the dentition or edentulous ridge. Handles or anterior projections are oriented along the arch axis and trimmed post-cure if they interfere with occlusion.
Build orientation in the printer is selected so that the tissue-facing surface is angled away from the build platform; this reduces support marks on the seating surface. The long arch segment is rotated relative to the peel direction to reduce the cross-section presented at each layer. Large flat tray floors are more sensitive to green-state peel deformation than contoured tray bodies; dividing a full-arch tray with a temporary scaffold or reorienting the arch reduces this effect. Marginal step artifacts at 100 µm layer thickness are finer than those at 160 µm, but the choice of layer thickness is constrained by print time and surface finish requirements.
Custom trays for edentulous arches require additional border extension and relief at the vestibular and posterior regions. The digital blockout is placed over the retromolar area, frena, and sharp bony contours. In partially dentate cases, the tray is designed with windows or perforations over the remaining teeth if a dual-arch or closed tray is not indicated. These windows are generated in CAD to reduce the risk of impression material tearing during removal; their edges are smoothed after post-cure. The positioning handle is located away from the occlusal plane to avoid interference with the opposing arch.
The printed tray is placed on the master cast before release to the clinic. The intaglio surface should show light, even contact on the tissue stops and no rocking over the blocked-out undercuts. Marginal extension is checked against the prescribed vestibular depth and posterior border. A sharp explorer or magnification is used to identify support remnants; any remnant on the tissue surface is removed before the tray is disinfected. Dimensional errors of clinical significance are traced to incorrect blockout, insufficient relief, or premature support removal rather than to the resin alone. If the tray requires border adjustment, a low-speed handpiece with a coarse acrylic bur is used; the ground edge is sealed with a light-cured resin if fibers or porosity are exposed.
For full-arch trays, the operator verifies that the posterior palatal border and mandibular retromolar extension match the digital prescription. A tray that binds on the master cast indicates inadequate blockout or distortion after post-cure. In such cases, the device should not be forced onto the cast; the intaglio surface is inspected for support remnants, undercured regions, or warpage at the tray floor. Dimensional acceptance is determined by passive seating on the master cast and by comparison of the printed margin to the CAD-defined border.
After printing, the green part is washed in ≥99% isopropanol in a Form Wash or equivalent agitated bath for 10–20 minutes. Inadequate washing leaves residual uncured resin in support pockets and around the tray borders; that residue can create a tacky surface after post-cure and may constitute a biocompatibility nonconformity. The part is dried until solvent is no longer visible on the surface. Post-curing is performed in a Form Cure at 60 °C for 20 minutes, after support removal. Support removal before curing reduces chipping because the polymerized supports are more brittle after full cure. The part should be placed on a clean glass surface and rotated halfway through the cure cycle.
If manual solvent washing is used, the solvent should be replaced frequently because dissolved resin raises the contamination level and can leave a film on the part. The table below lists the process window variables that should be recorded in the device record.
| Processing variable | Control range | Context |
|---|---|---|
| Storage temperature | 10–30 °C | Sealed cartridge, no UV exposure |
| Layer thickness | 100 µm or 160 µm | Dental tray profile |
| Wash solvent | ≥99% isopropanol | Form Wash or equivalent agitation |
| Wash duration | 10–20 min | Single or dual stage; inspect for residue |
| Post-cure temperature | 60 °C | Form Cure recommended |
| Post-cure duration | 20 min | After support removal |
Support removal is performed with a flush cutter or scalpel before post-cure; the gate marks are reduced with a fine diamond or acrylic bur. Dry polishing is limited because frictional heat can soften the resin surface above 60 °C. Wet pumice and water on a lathe or rotary handpiece produce a smooth peripheral border without excessive heat. The finished tray is inspected under magnification for voids, delamination, or support remnants. If a void is found in a noncritical area, it may be repaired with a small addition of light-cured tray resin and re-cured according to the repair resin instructions, but repairs in the tissue-bearing area are generally not recommended because they alter the intaglio surface and may create a mismatch with the master cast.
Disinfection is carried out with a non-immobilizing agent compatible with the cured resin. Autoclaving is not recommended because the resin can soften or distort. The disinfection method should be validated by the dental laboratory for the specific bioburden risk. After disinfection, the tray is packaged with a model or support block to prevent deformation during storage and transport. The device record should include the disinfectant lot and contact time.
Compared with general-purpose model resins, Custom Tray Resin is positioned for short-term intraoral use and is supplied with documentation that supports this indication under current EN ISO 10993 guidance. Model resins are not generally intended for mucosal contact and should not be substituted. Compared with denture base resins, the tray resin is not intended to resist masticatory loading as a final prosthetic; it is formulated for impression tray rigidity, support handling, and post-finishing operations. The resin is also distinct from thermoformed tray blanks because it reproduces digital blockout and tissue stops directly from the CAD file, which reduces manual adaptation but requires strict printer and post-processing control.
The material is used for custom trays that receive elastomeric impression materials. A residual adhesive layer is required for most addition-cured silicone impression materials; the operator should verify tray adhesive compatibility on a cured resin coupon because residual surface energy and cleaning agents can alter adhesive film formation. The printed tray is not a substitute for final prosthesis; it is an impression-transfer device.
From a processing standpoint, the cartridged resin is dispensed automatically from the printer, so lot-to-lot viscosity variations are managed through manufacturer QC rather than through operator mixing. Powder-liquid tray acrylics require proportioning and heat-cure or self-cure cycles that introduce porosity and dimensional change; the printed resin instead requires careful wash and post-cure control. The occupational exposure profile also differs: the liquid photopolymer is an irritant and requires liquid resin handling controls, while powder-liquid systems primarily require dust and monomer controls. The disposal path for uncured resin, wash solvent, and support material is governed by local hazardous waste regulations; cured support waste is typically disposed of as solid polymer waste.
| Resin type | Typical use | Intraoral documentation | Processing note |
|---|---|---|---|
| Custom Tray Resin | Impression trays, tray bases | Short-term mucosal contact per manufacturer IFU | Dedicated tank; wash and post-cure required |
| General-purpose model resin | Diagnostic casts, models | Not indicated for intraoral use | No biocompatibility expectation |
| Denture base resin | Prosthetic baseplates | Long-term or repeated contact per material-specific documentation | Different post-cure and mechanical validation |
Cross-contamination risk arises when the same tank, build platform, or cleaning bath is used for Custom Tray Resin and other Formlabs materials. Residual droplets of model resin can float on the resin surface or redissolve in the wash solvent, producing localized cure inhibition, sticky patches, or white haze on the tray surface. A dedicated tank should be assigned to Custom Tray Resin. If a changeover is unavoidable, the tank should be drained, filtered, and wiped with ≥99% isopropanol, and the wiper and resin distributor should be inspected before refilling. The wash bath must also be segregated because dissolved model resin can contaminate the rinsed tray surface and change the final surface energy.
Failure to separate the material can create batch-level compliance problems: a tray printed from contaminated resin may not meet the declared biocompatibility expectation because the contaminants are not part of the validated formulation. Documented resin lot number, tank assignment, and wash bath change date should be recorded in the production record. The manufacturer’s instructions for use list dedicated-use consumables as the recommended practice; independent verification data for mixed-resin failure rates is limited.
Regulatory acceptance of the printed device remains the responsibility of the dental laboratory and prescribing clinician. The material should be received with current instructions for use, safety data sheet, and any applicable certificates. The device record should document resin lot number, printer serial number, wash solvent lot, wash duration, cure temperature, cure time, and post-finishing inspection result. Deviations such as solvent concentration below 99%, cure time below 20 minutes, or storage above 30 °C should be evaluated as nonconforming because final degree of conversion and dimensional stability may fall outside the validated process window. Before adoption, the laboratory should consult the current Proto3000 technical datasheet and Formlabs Instructions for Use for the specific printer generation. Published independent comparative data for mixed-resin contamination and clinical tray failure rates is limited; process controls therefore rely on manufacturer-recommended dedicated-use consumables and documented processing.
