The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-dent Hema Desentizer(748-000)/with Fluoride(747-000).
| Device ID | K960365 |
| 510k Number | K960365 |
| Device Name: | ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago, IL 60614 |
| Contact | Abner T De La Cruz |
| Correspondent | Abner T De La Cruz WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago, IL 60614 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-25 |
| Decision Date | 1996-03-28 |