The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Bisco Porcelain Repair Kit.
| Device ID | K874557 |
| 510k Number | K874557 |
| Device Name: | BISCO PORCELAIN REPAIR KIT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-04 |
| Decision Date | 1988-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757B32120 | K874557 | 000 |
| 10810111542415 | K874557 | 000 |
| 00810111542425 | K874557 | 000 |
| 10810111540114 | K874557 | 000 |
| 00810111540100 | K874557 | 000 |
| 00810111540087 | K874557 | 000 |
| 00810111540094 | K874557 | 000 |
| D757B21120 | K874557 | 000 |
| D757B2112Q1 | K874557 | 000 |
| D757B21220 | K874557 | 000 |
| D757B2122Q1 | K874557 | 000 |
| D757B22210 | K874557 | 000 |
| D757B2221P1 | K874557 | 000 |
| D757B2223P0 | K874557 | 000 |
| D757B3210P1 | K874557 | 000 |
| D757B32110 | K874557 | 000 |
| 00810111540124 | K874557 | 000 |