The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Non-eugenol Temporary Cement.
| Device ID | K020158 |
| 510k Number | K020158 |
| Device Name: | NON-EUGENOL TEMPORARY CEMENT |
| Classification | Zinc Oxide Eugenol |
| Applicant | J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
| Contact | Keith A Barritt |
| Correspondent | Keith A Barritt J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
| Product Code | EMB |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-17 |
| Decision Date | 2002-03-07 |