The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-dent Copal Cavity Varnish.
Device ID | K955521 |
510k Number | K955521 |
Device Name: | ALPHA-DENT COPAL CAVITY VARNISH |
Classification | Varnish, Cavity |
Applicant | WALLACE A. ERICKSON & CO. 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
Contact | Abner T De La Cruz |
Correspondent | Abner T De La Cruz WALLACE A. ERICKSON & CO. 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-04 |
Decision Date | 1996-01-24 |