K991913 is an FDA 510(k) clearance for the PENTAMIX 2. This device is classified as a Amalgamator, Dental, Ac-powered (Class I - General Controls, product code EFD).
Submitted by Espe Dental AG (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on July 26, 1999, 49 days after receiving the submission on June 7, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3100.
| 510(k) Number | K991913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1999 |
| Decision Date | July 26, 1999 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFD — Amalgamator, Dental, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3100 |