K221851 is an FDA 510(k) clearance for the Lumina-PTFE Titanium. This device is classified as a Barrier, Synthetic, Intraoral (Class II - Special Controls, product code NPK).
Submitted by Criteria Industria E Comercio DE Produtos Medicinais (Sao Carlos, BR). The FDA issued a Cleared decision on December 8, 2023, 529 days after receiving the submission on June 27, 2022.
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 | K221851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2022 |
| Decision Date | December 08, 2023 |
| Days to Decision | 529 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. |