K922627 is an FDA 510(k) clearance for the GORE-TEX REGENERATIVE MATERIAL. This device is classified as a Barrier, Synthetic, Intraoral (Class II - Special Controls, product code NPK).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 10, 1994, 737 days after receiving the submission on June 3, 1992.
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 | K922627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1992 |
| Decision Date | June 10, 1994 |
| Days to Decision | 737 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| 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. |