The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Porcelain Veneer Resin Cement W/dual Cure Catalyst.
Device ID | K875313 |
510k Number | K875313 |
Device Name: | PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST |
Classification | Material, Tooth Shade, 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 | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-29 |
Decision Date | 1988-03-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D82813306010 | K875313 | 000 |
D867CLEGS0 | K875313 | 000 |
D867CLEG0 | K875313 | 000 |