The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-dent Tissue Conditioner And Temporary Reliner.
| Device ID | K934248 |
| 510k Number | K934248 |
| Device Name: | ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-30 |
| Decision Date | 1993-12-08 |