The following data is part of a premarket notification filed by Dmg Hamburg with the FDA for Ecusit Composite Repair.
| Device ID | K992879 |
| 510k Number | K992879 |
| Device Name: | ECUSIT COMPOSITE REPAIR |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DMG HAMBURG 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau DMG HAMBURG 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-26 |
| Decision Date | 1999-11-09 |
| Summary: | summary |