The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alphadent Light Activated Orthodontic Adhesive Bonding System With Fluoride.
| Device ID | K935625 |
| 510k Number | K935625 |
| Device Name: | ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE |
| 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 | 1993-11-22 |
| Decision Date | 1994-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190707041243 | K935625 | 000 |
| D73520801010010 | K935625 | 000 |
| D73520801020010 | K935625 | 000 |
| 00190707041229 | K935625 | 000 |
| 00190707041236 | K935625 | 000 |
| 00817713022942 | K935625 | 000 |
| 00817713022959 | K935625 | 000 |
| 00190707000707 | K935625 | 000 |
| 00190707008239 | K935625 | 000 |
| 00190707010812 | K935625 | 000 |
| 00190707011109 | K935625 | 000 |
| 10817713022970 | K935625 | 000 |