The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for All-bond Universal Sc (not Finalized).
| Device ID | K131734 |
| 510k Number | K131734 |
| Device Name: | ALL-BOND UNIVERSAL SC (NOT FINALIZED) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-13 |
| Decision Date | 2014-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757B4110P1 | K131734 | 000 |
| D757B41020 | K131734 | 000 |
| D757B41010 | K131734 | 000 |
| 00810111542463 | K131734 | 000 |
| 00810111542456 | K131734 | 000 |
| 00810111542449 | K131734 | 000 |
| D757B412010 | K131734 | 000 |