FDA Registration
Active
🇺🇸 United States
Biotech Dental
Reg #: 3010730876
·
FEI: 3010730876
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- Biotech Dental
- Registration Number
- 3010730876
- FEI Number
- 3010730876
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | QBV | Class 1 | Clinical Chemistry | No | 2025-12-22 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2026-01-06 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-12-22 |
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2021-12-20 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2022-02-17 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2025-12-22 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-12-22 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-12-20 |
Proprietary Names
PRF System
Y-Brush
ATP38
Implant Surgical Kit
Implant Prosthetic Kit
Smilers
Kontact
Reflect
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device