Data / Medical devices / United States / Formlabs Inc.
Formlabs Inc.: FDA-registered device maker in Somerville, MA, United States, 4 510(k) clearances
Formlabs Inc. is registered with the FDA (registration 3010279788) in Somerville, MA, United States. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010279788
- Address
- 35 Medford St, Somerville, MA, United States, 02143
- Owner or operator
- Formlabs Inc. (10060005)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 11, 2011
- Registered through
- 2026
- Brand names listed
- Custom Tray Resin, Dental LT Clear V2 Resin, Dental LT Comfort Resin, Denture Base Resin V2, H-0600 Resin, IBT Flex Resin, IBT Resin, Premium Teeth Resin and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Spoon, Ophthalmic | HNB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 8, 2026 | K262300 | Denture Base Resin V2 | EBI | Substantially Equivalent | Formlabs Ohio, Inc. | accessdata.fda.gov |
| July 19, 2024 | K240538 | Premium Teeth Resin | EBG | Substantially Equivalent | Formlabs Ohio, Inc. | accessdata.fda.gov |
| February 16, 2024 | K232087 | Dental LT Comfort Resin | MQC | Substantially Equivalent | Formlabs Ohio, Inc. | accessdata.fda.gov |
| November 10, 2022 | K222061 | Dental LT Clear V2 Resin | MQC | Substantially Equivalent | Formlabs Ohio, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Mouthguard, Prescription
- All makers of Maintainer, Space Preformed, Orthodontic
- All makers of Positioner, Tooth, Preformed
- All makers of Spoon, Ophthalmic
Updated July 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.