The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Excel Bond Dc, Model 28-200100.
| Device ID | K060882 |
| 510k Number | K060882 |
| Device Name: | EXCEL BOND DC, MODEL 28-200100 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Contact | Howard Rowe |
| Correspondent | Howard Rowe J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-31 |
| Decision Date | 2006-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18522530060204 | K060882 | 000 |
| 18522530060198 | K060882 | 000 |
| 18522530060181 | K060882 | 000 |
| 10852253006202 | K060882 | 000 |
| 10852253006196 | K060882 | 000 |
| 10852253006189 | K060882 | 000 |