FDA Registration
Active
🇺🇸 United States
N1 TiUltra TCC Implant System
Reg #: 3008325990
·
FEI: 3008325990
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Toothsmiths Incorporated
- Registration Number
- 3008325990
- FEI Number
- 3008325990
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 24 E Woods Dr
- City
- Lititz
- State
- PA
- ZIP
- 17543
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211109
Owner / Operator
- Firm Name
- Toothsmiths Dental Lab
- Operator Number
- 10079418
- Address
- 39 E Woods Dr
- City
- Lititz
- State
- PA
- Postal Code
- 17543
- Country
- US
- Correspondent
- Jim Ament
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2023-07-25 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2023-07-25 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2023-07-25 |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | Class 1 | Dental | No | 2023-07-25 |
Proprietary Names
N1 TiUltra TCC Implant System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)