The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Self Adhesive Composite Luting Cement.
| Device ID | K093338 |
| 510k Number | K093338 |
| Device Name: | SELF ADHESIVE COMPOSITE LUTING CEMENT |
| Classification | Cement, Dental |
| Applicant | DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-23 |
| Decision Date | 2010-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2133681 | K093338 | 000 |
| EDMG2133671 | K093338 | 000 |
| EDMG2133661 | K093338 | 000 |