The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Porcelain Primer.
| Device ID | K061322 |
| 510k Number | K061322 |
| Device Name: | PORCELAIN PRIMER |
| 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 | 2006-05-11 |
| Decision Date | 2006-06-02 |