The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Bisfil 2b.
| Device ID | K964000 |
| 510k Number | K964000 |
| Device Name: | BISFIL 2B |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Contact | James L Sandrik |
| Correspondent | James L Sandrik BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1996-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757A1264K1 | K964000 | 000 |
| 00810111542128 | K964000 | 000 |
| 00810111542098 | K964000 | 000 |
| 00810111542074 | K964000 | 000 |
| 00810111542081 | K964000 | 000 |
| D757A12510 | K964000 | 000 |
| D757A12530 | K964000 | 000 |
| D757A127110 | K964000 | 000 |
| D757A128110 | K964000 | 000 |
| D757A12610 | K964000 | 000 |
| D757A1254P1 | K964000 | 000 |
| 00810111542104 | K964000 | 000 |