K142712 is an FDA 510(k) clearance for the Dental Collagen Wound Dressing (Nova Tape and NovaPlug). This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Novabone Products, LLC (Alachua, US). The FDA issued a Cleared decision on January 8, 2015, 108 days after receiving the submission on September 22, 2014.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K142712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2014 |
| Decision Date | January 08, 2015 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |