K991172 is an FDA 510(k) clearance for the IONOSIT BOND. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Dmg Chemisch Pharmazeutische Fabrik GmbH (Ayer, US). The FDA issued a Cleared decision on May 17, 1999, 40 days after receiving the submission on April 7, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K991172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1999 |
| Decision Date | May 17, 1999 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA - Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |