K100156 is an FDA 510(k) clearance for the COLLAGEN DENTAL MEMBRANE V. This device is classified as a Barrier, Animal Source, Intraoral (Class II - Special Controls, product code NPL).
Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on August 11, 2010, 203 days after receiving the submission on January 20, 2010.
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 | K100156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2010 |
| Decision Date | August 11, 2010 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| 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. |