K143465 is an FDA 510(k) clearance for the MASTERmatic LUX. This device is classified as a Handpiece, Belt And/or Gear Driven, Dental (Class I - General Controls, product code EFA).
Submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on April 9, 2015, 126 days after receiving the submission on December 4, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K143465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2014 |
| Decision Date | April 09, 2015 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFA - Handpiece, Belt And/or Gear Driven, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |