Data / Medical devices / United States / Boca Dental Regenerative, LLC.
Boca Dental Regenerative, LLC.: FDA-registered device maker in Boca Raton, FL, United States, 2 510(k) clearances
Boca Dental Regenerative, LLC. is registered with the FDA (registration 3021169199) in Boca Raton, FL, United States. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 14, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021169199
- Address
- 3401 N. Federal Hwy. suite 211, Boca Raton, FL, United States, 33431
- Owner or operator
- Boca Dental Regenerative, LLC. (10083275)
- Roles
- Complaint file establishment
- First device listed
- November 8, 2021
- Registered through
- 2026
- Brand names listed
- Boca Dental regenerative
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | QBV | 1 | Complaint file establishment | accessdata.fda.gov |
| Centrifuge, Blood-Bank For In Vitro Diagnostic Use | KSO | 1 | Complaint file establishment | accessdata.fda.gov |
| Centrifuge, Microsedimentation | GHK | 1 | Complaint file establishment | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Complaint file establishment | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Complaint file establishment | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Complaint file establishment | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 14, 2017 | K163093 | Safety Blood Collection Set | FMI | Substantially Equivalent | Jiangsu Shenli Medical Production Co., Ltd. | accessdata.fda.gov |
| August 25, 2009 | K091292 | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 | JKA | Substantially Equivalent | Becton, Dickinson and Company (BD) | accessdata.fda.gov |
Compare with other makers
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Instruments, Dental Hand
- All makers of Centrifuge, Microsedimentation
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of File, Bone, Surgical
- All makers of Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
Updated March 14, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.