FDA Registration
Active
🇺🇸 United States
SMILESET ALIGNERS
Reg #: 3032193293
·
FEI: 3032193293
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORTHO DENTAL LAB, LLC
- Registration Number
- 3032193293
- FEI Number
- 3032193293
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1530 Antioch Pike
- City
- Antioch
- State
- TN
- ZIP
- 37013
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220726
Owner / Operator
- Firm Name
- Ortho Dental Lab, LLC
- Operator Number
- 10091367
- Address
- 1530 Antioch Pike
- City
- Antioch
- State
- TN
- Postal Code
- 37013
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2025-03-11 |
Proprietary Names
SMILESET ALIGNERS
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device