K201187 is an FDA 510(k) clearance for the Cytoplast Titanium-Reinforced PTFE Membranes. This device is classified as a Barrier, Synthetic, Intraoral (Class II - Special Controls, product code NPK).
Submitted by Osteogenics Biomedical, Inc. (Lubbock, US). The FDA issued a Cleared decision on January 23, 2021, 267 days after receiving the submission on May 1, 2020.
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 | K201187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2020 |
| Decision Date | January 23, 2021 |
| Days to Decision | 267 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. |