The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for All-bond Dentin Bonding System.
| Device ID | K897020 |
| 510k Number | K897020 |
| Device Name: | ALL-BOND DENTIN BONDING SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | BISCO, INC. 3010-J WOODCREEK DR. Downers Grove, IL 60515 -5409 |
| Contact | Byoung I Suh |
| Correspondent | Byoung I Suh BISCO, INC. 3010-J WOODCREEK DR. Downers Grove, IL 60515 -5409 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-19 |
| Decision Date | 1990-03-14 |