The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Resilience M5 Protection Plus.
Device ID | K955329 |
510k Number | K955329 |
Device Name: | RESILIENCE M5 PROTECTION PLUS |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
Contact | Sharon A Lutton |
Correspondent | Sharon A Lutton CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-20 |
Decision Date | 1996-03-28 |