The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Ortho-1(not Finalized).
| Device ID | K113401 |
| 510k Number | K113401 |
| Device Name: | ORTHO-1(NOT FINALIZED) |
| Classification | Adhesive, Bracket And Tooth Conditioner, 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 | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-17 |
| Decision Date | 2012-02-07 |
| Summary: | summary |