The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Carbon Post.
| Device ID | K012496 |
| 510k Number | K012496 |
| Device Name: | CARBON POST |
| Classification | Post, Root Canal |
| 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 | ELR |
| CFR Regulation Number | 872.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-03 |
| Decision Date | 2002-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852253006274 | K012496 | 000 |