K854299 is an FDA 510(k) clearance for the GORE-TEX PERIODONTAL 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 May 19, 1986, 206 days after receiving the submission on October 25, 1985.
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 | K854299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1985 |
| Decision Date | May 19, 1986 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| 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. |