Manufacturer registered with FDA
Formlabs Inc.
Somerville, MA, United States. Lists 7 dental device types with FDA across 2 registered establishments, and holds 2 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 11
- 510(k) clearances
- 22024–2026
- Markets registered in
- 1035 registrations outside the US
- Establishments
- 2United States
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Formlabs Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Formlabs Inc. | 2 clearances | 2024–2026 | Below |
| Canada | Health Canada | Registration holder | FORMLABS INC.FORMLABS OHIO, INC | 9 | 2020–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Formlabs Ohio Inc. | 8 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | FORMLABS INC. | 4 | 2018–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Formlabs Ohio, Inc. | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Formlabs Ohio, Inc. | 3 | 2022–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Formlabs Ohio Inc. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Formlabs Inc. | 2 | 2020–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | Formlabs Ohio Inc | 1 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Formlabs Ohio Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Formlabs Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Dental LT Clear V2 ResinDental LT Comfort Resin | 2022 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Dental LT Clear V2 Resin | 2022 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Premium Teeth Resin | 2024 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Custom Tray ResinH-0600 ResinIBT Flex ResinIBT Resin | 2020 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Denture Base Resin V2 | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Surgical Guide Resin | 2019 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Premium Teeth Resin | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Formlabs Inc. as the applicant, including filings under its other names.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Formlabs Inc.FDA reg. 3010279788 | Somerville, MA, United States | Complaint file establishment, Specification developer |
| Formlabs Ohio, Inc.FDA reg. 3015491441 | Millbury, OH, United States | Complaint file establishment, Manufacturer |
Other names on FDA records
Formlabs Ohio Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060005). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.