K161762 is an FDA 510(k) clearance for the DynaMatrix/Dynamatrix Plus. This device is classified as a Barrier, Animal Source, Intraoral (Class II - Special Controls, product code NPL).
Submitted by Cook Biotech Incorporated (West Lafayetta, US). The FDA issued a Cleared decision on January 13, 2017, 200 days after receiving the submission on June 27, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3930. An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants..
| 510(k) Number | K161762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2016 |
| Decision Date | January 13, 2017 |
| Days to Decision | 200 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NPL — Barrier, Animal Source, Intraoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3930 |
| Definition | An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants. |