The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Centrix Tri-laminate Post System.
Device ID | K882125 |
510k Number | K882125 |
Device Name: | CENTRIX TRI-LAMINATE POST SYSTEM |
Classification | Post, Root Canal |
Applicant | CENTRIX, INC. 30 STRAN RD. Milford, CT 06460 |
Contact | John Discko |
Correspondent | John Discko CENTRIX, INC. 30 STRAN RD. Milford, CT 06460 |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-20 |
Decision Date | 1988-08-11 |