The following data is part of a premarket notification filed by L.d. Caulk Co. with the FDA for Cement, Resin Dental (auto-tach).
Device ID | K760378 |
510k Number | K760378 |
Device Name: | CEMENT, RESIN DENTAL (AUTO-TACH) |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | L.D. CAULK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-05 |
Decision Date | 1976-08-23 |