K012316 is an FDA 510(k) clearance for the PERMACEM / PERMACEM DUAL. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Dmg USA, Inc. (Dover, US). The FDA issued a Cleared decision on August 23, 2001, 31 days after receiving the submission on July 23, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K012316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2001 |
| Decision Date | August 23, 2001 |
| Days to Decision | 31 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |