FDA Registration
Active
🇺🇸 United States
Formlabs Inc.
Reg #: 3010279788
·
FEI: 3010279788
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Formlabs Inc.
- Registration Number
- 3010279788
- FEI Number
- 3010279788
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 35 Medford St
- City
- Somerville
- State
- MA
- ZIP
- 02143
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232087
Owner / Operator
- Firm Name
- Formlabs Inc.
- Operator Number
- 10060005
- Address
- 35 Medford St
- City
- Somerville
- State
- MA
- Postal Code
- 02143
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2024-02-29 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2024-02-29 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2011-03-11 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2020-06-23 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2024-08-14 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2024-08-14 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2019-03-19 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2022-12-22 |
Proprietary Names
Dental LT Comfort Resin
Custom Tray Resin
IBT Resin
IBT Flex Resin
H-0600 Resin
Premium Teeth Resin
Surgical Guide Resin
Dental LT Clear V2 Resin
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198