FDA Registration
Active
🇺🇸 United States
Reflect Certus Surgical Kit
Reg #: 3010730876
·
FEI: 3010730876
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
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
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 |
|---|---|---|---|---|---|
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2021-12-20 |
Proprietary Names
Reflect Certus Surgical Kit
Reflect Rapid Surgical Kit
Reflect Tapered Surgical Kit
Reflect Aspire Surgical Kit
Accelx Prosthetic Kit
Reflect Recover Surgical Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198