The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for All-bound 3.
| Device ID | K102844 |
| 510k Number | K102844 |
| Device Name: | ALL-BOUND 3 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Michelle Schiltz-taing |
| Correspondent | Michelle Schiltz-taing BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757B3602P1 | K102844 | 000 |
| D757B3605PS1 | K102844 | 000 |
| 00810111540391 | K102844 | 000 |
| 00810111540377 | K102844 | 000 |
| 00810111540384 | K102844 | 000 |
| D757B36010 | K102844 | 000 |
| D757B36010P1 | K102844 | 000 |
| D757B36020 | K102844 | 000 |
| D757B3601P1 | K102844 | 000 |
| D757B36050 | K102844 | 000 |