K101064 is an FDA 510(k) clearance for the BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P. This device is classified as a Denture, Plastic, Teeth (Class II - Special Controls, product code ELM).
Submitted by Bredent GmbH & Co. KG (Tuttlingen, Baden Wurttemberg, DE). The FDA issued a Cleared decision on September 14, 2010, 151 days after receiving the submission on April 16, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3590.
| 510(k) Number | K101064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2010 |
| Decision Date | September 14, 2010 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELM - Denture, Plastic, Teeth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3590 |