The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Hydroxylate Enamel Bond System.
| Device ID | K810407 |
| 510k Number | K810407 |
| Device Name: | HYDROXYLATE ENAMEL BOND SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | WALLACE A. ERICKSON & CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-18 |
| Decision Date | 1981-03-17 |