The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Secure Anti-rotational Post-core System.
Device ID | K870130 |
510k Number | K870130 |
Device Name: | DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM |
Classification | Post, Root Canal |
Applicant | DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
Contact | Robert L Ibsen |
Correspondent | Robert L Ibsen DEN-MAT CORP. P.O. BOX 1729 Santa Maria, CA 93456 |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-12 |
Decision Date | 1987-02-19 |