K122039 is an FDA 510(k) clearance for the KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Kettenbach GmbH & Co. KG (Eschenburg, DE). The FDA issued a Cleared decision on December 27, 2012, 169 days after receiving the submission on July 11, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K122039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2012 |
| Decision Date | December 27, 2012 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG - Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |