The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-dent C-r(r) Hybrid Type Ii Composite Resin.
| Device ID | K942767 |
| 510k Number | K942767 |
| Device Name: | ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN |
| Classification | Material, Tooth Shade, Resin |
| Applicant | WALLACE A. ERICKSON & CO. 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
| Contact | George Nicolae |
| Correspondent | George Nicolae WALLACE A. ERICKSON & CO. 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-13 |
| Decision Date | 1994-07-08 |