The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Composite/compomer Repair Kit.
| Device ID | K041960 |
| 510k Number | K041960 |
| Device Name: | COMPOSITE/COMPOMER REPAIR KIT |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DMG USA, INC. 414 SOUTH STATE ST. Dover, DE 19901 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau DMG USA, INC. 414 SOUTH STATE ST. Dover, DE 19901 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-21 |
| Decision Date | 2004-08-30 |
| Summary: | summary |