The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Total Etch Bonding Agent.
| Device ID | K063444 |
| 510k Number | K063444 |
| Device Name: | TOTAL ETCH BONDING AGENT |
| Classification | Agent, Tooth Bonding, Resin |
| 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2007-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG2133201 | K063444 | 000 |
| EDMG2123841 | K063444 | 000 |