The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-lock Or Pro-lock Fluoride Releasing Glass Ionomer Band Cement.
| Device ID | K942596 |
| 510k Number | K942596 |
| Device Name: | ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT |
| Classification | Cement, Dental |
| Applicant | WALLACE A. ERICKSON & CO. 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
| Contact | George Nicolae, Ph.d. |
| Correspondent | George Nicolae, Ph.d. WALLACE A. ERICKSON & CO. 1920 N. CLYBOURN AVE. Chicago, IL 60614 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-01 |
| Decision Date | 1994-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817713022997 | K942596 | 000 |