The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha Bond Dentin/enamel Bonding Agent, Model 213-000.
| Device ID | K984503 |
| 510k Number | K984503 |
| Device Name: | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 |
| 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 | 1998-12-18 |
| Decision Date | 1999-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00766054000341 | K984503 | 000 |
| D73520000010010 | K984503 | 000 |
| D73520001020010 | K984503 | 000 |
| D73520002020010 | K984503 | 000 |
| D73520601010010 | K984503 | 000 |
| D73520601020010 | K984503 | 000 |
| D73521100010020 | K984503 | 000 |
| D73521102010020 | K984503 | 000 |
| D73521104010020 | K984503 | 000 |
| 00190707000684 | K984503 | 000 |
| D73520000000010 | K984503 | 000 |