K210797 is an FDA 510(k) clearance for the Bio-MEM Ti Reinforced Membrane. This device is classified as a Barrier, Synthetic, Intraoral (Class II - Special Controls, product code NPK).
Submitted by B&Medi Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on August 18, 2022, 520 days after receiving the submission on March 16, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3930. A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials..
| 510(k) Number | K210797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2021 |
| Decision Date | August 18, 2022 |
| Days to Decision | 520 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NPK - Barrier, Synthetic, Intraoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3930 |
| Definition | A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials. |