The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Formcore Dc, Model 28-700100.
| Device ID | K061664 |
| 510k Number | K061664 |
| Device Name: | FORMCORE DC, MODEL 28-700100 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Contact | Takeshi Inoue |
| Correspondent | Takeshi Inoue J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-14 |
| Decision Date | 2006-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18522530060211 | K061664 | 000 |
| 10852253006219 | K061664 | 000 |