The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Bisfil-ii(chemical Curable Posterior/anterior).
| Device ID | K853002 |
| 510k Number | K853002 |
| Device Name: | BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR) |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BISCO, INC. 765 SPRINGER DR. Lombard, IL 60148 |
| Contact | Byoung I Sun |
| Correspondent | Byoung I Sun BISCO, INC. 765 SPRINGER DR. Lombard, IL 60148 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-16 |
| Decision Date | 1985-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757A1234P0 | K853002 | 000 |
| D757A1233P0 | K853002 | 000 |
| D757A1232P0 | K853002 | 000 |
| D757A1231P0 | K853002 | 000 |
| D757A1214P0 | K853002 | 000 |
| D757A1213P0 | K853002 | 000 |
| D757A1202P0 | K853002 | 000 |
| D757A1201P0 | K853002 | 000 |