FDA Registration
Active
🇺🇸 United States
BOCA DENTAL REGENERATIVE, LLC.
Reg #: 3021169199
·
FEI: 3021169199
·
Expires 2026
Products
9
Proprietary Names
1
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- BOCA DENTAL REGENERATIVE, LLC.
- Registration Number
- 3021169199
- FEI Number
- 3021169199
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3401 N. Federal Hwy., suite 211
- City
- Boca Raton
- State
- FL
- ZIP
- 33431
- Country
- US
Regulatory Submissions
- 510(k) Number
- K091292
Owner / Operator
- Firm Name
- Boca Dental Regenerative, LLC.
- Operator Number
- 10083275
- Address
- 3401 N. Federal Hwy., suite 212
- City
- Boca Raton
- State
- FL
- Postal Code
- 33431
- Country
- US
- Correspondent
- Alvaro Betancur
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2021-11-08 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2021-11-08 |
| Centrifuge, Microsedimentation | GHK | Class 1 | Hematology | No | 2022-03-15 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2021-11-08 |
| Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | QBV | Class 1 | Clinical Chemistry | No | 2021-11-08 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2021-11-08 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2022-03-15 |
| Centrifuge, Blood-Bank For In Vitro Diagnostic Use | KSO | Class 1 | Hematology | No | 2021-11-08 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-11-08 |
Proprietary Names
Boca Dental regenerative
Establishment Types
Complaint File Establishment per 21 CFR 820.198