The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Ad Post.
Device ID | K884277 |
510k Number | K884277 |
Device Name: | AD POST |
Classification | Post, Root Canal |
Applicant | J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
Contact | Ronald D Newman |
Correspondent | Ronald D Newman J. MORITA USA, INC. 9 MASON Irvine, CA 92618 |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-12 |
Decision Date | 1988-12-22 |