FDA Registration
Active
🇺🇸 United States
Surgical Guide Resin
Reg #: 3010279788
·
FEI: 3010279788
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Formlabs Inc.
- Registration Number
- 3010279788
- FEI Number
- 3010279788
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 35 Medford St
- City
- Somerville
- State
- MA
- ZIP
- 02143
- Country
- US
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 |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2019-03-19 |
Proprietary Names
Surgical Guide Resin
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198