The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for All-etch, All- Etch With Bac; Uni- Etch, Uni- Etch With Bac; Etch- 37, Etch- 37 With Bac; Dark- Etch, Dark Etch (blue- E.
| Device ID | K101485 |
| 510k Number | K101485 |
| Device Name: | ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Michelle Schultz- Taing |
| Correspondent | Michelle Schultz- Taing BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-28 |
| Decision Date | 2010-08-26 |
| Summary: | summary |