K161488 is an FDA 510(k) clearance for the ESTETICA Dental Treatment Unit and Accessories. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Kaltenbach & Voigt GmbH (Biberach, DE). The FDA issued a Cleared decision on December 8, 2016, 190 days after receiving the submission on June 1, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K161488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2016 |
| Decision Date | December 08, 2016 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA - Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |