FDA Registration
Active
🇺🇸 United States
Smilers
Reg #: 3010730876
·
FEI: 3010730876
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Biotech Dental
- Registration Number
- 3010730876
- FEI Number
- 3010730876
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 145 Cedar Lane, Suite 205
- City
- Englewood
- State
- NJ
- ZIP
- 07631
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212961
Owner / Operator
- Firm Name
- Biotech Dental
- Operator Number
- 10083785
- Address
- 145 Cedar Lane, Suite 205
- City
- Englewood
- State
- NJ
- Postal Code
- 07631
- Country
- US
- Correspondent
- David Singh
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2022-02-17 |
Proprietary Names
Smilers
Establishment Types
Complaint File Establishment per 21 CFR 820.198