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 |