The following data is part of a premarket notification filed by L.d. Caulk Co. with the FDA for Filling, Resin Dental (vytol).
Device ID | K760377 |
510k Number | K760377 |
Device Name: | FILLING, RESIN DENTAL (VYTOL) |
Classification | Material, Tooth Shade, Resin |
Applicant | L.D. CAULK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-05 |
Decision Date | 1976-08-23 |