The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Resilience C2, Resilience L3 & Resilience P4.
Device ID | K891464 |
510k Number | K891464 |
Device Name: | RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4 |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
Contact | Brahma D Sharma |
Correspondent | Brahma D Sharma CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-15 |
Decision Date | 1989-05-18 |