The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for All-bond 2.
| Device ID | K910860 |
| 510k Number | K910860 |
| Device Name: | ALL-BOND 2 |
| 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 | 1991-02-20 |
| Decision Date | 1991-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757B36040 | K910860 | 000 |
| 00810111541954 | K910860 | 000 |
| 00810111542005 | K910860 | 000 |
| 00810111541985 | K910860 | 000 |
| 10810111541944 | K910860 | 000 |
| 10810111541937 | K910860 | 000 |
| 10810111540428 | K910860 | 000 |
| 10810111541999 | K910860 | 000 |
| D757U30120 | K910860 | 000 |
| D757U3011S0 | K910860 | 000 |
| D757B36080 | K910860 | 000 |
| D757B3608P1 | K910860 | 000 |
| D757B25010 | K910860 | 000 |
| D757U30150 | K910860 | 000 |
| D757B2512A1 | K910860 | 000 |
| D757B25120 | K910860 | 000 |
| D757B2511A1 | K910860 | 000 |
| D757B25110 | K910860 | 000 |
| D757B2510A1 | K910860 | 000 |
| D757B2506A1 | K910860 | 000 |
| D757B2502A1 | K910860 | 000 |
| D757B25020 | K910860 | 000 |
| D757B2501A1 | K910860 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ALL-BOND 2 78321098 2965007 Live/Registered |
Bisco, Inc. 2003-10-30 |