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 |