K041960 is an FDA 510(k) clearance for the COMPOSITE/COMPOMER REPAIR KIT. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Dmg USA, Inc. (Dover, US). The FDA issued a Cleared decision on August 30, 2004, 40 days after receiving the submission on July 21, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K041960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2004 |
| Decision Date | August 30, 2004 |
| Days to Decision | 40 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLE — Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |