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 |