The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-dent Orthodontic Adhesive With One Step Bond.
| Device ID | K921044 |
| 510k Number | K921044 |
| Device Name: | ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| 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 | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-04 |
| Decision Date | 1992-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190730004512 | K921044 | 000 |
| 00190730004505 | K921044 | 000 |
| 00190730004499 | K921044 | 000 |
| 00190707000714 | K921044 | 000 |
| D73520901010010 | K921044 | 000 |