The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha Bound-rite I No-mix Adhesive Or Bond-rite I No-mix Adhesive.
| Device ID | K942727 |
| 510k Number | K942727 |
| Device Name: | ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| 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 | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-09 |
| Decision Date | 1994-08-23 |