The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Ortho-one.
| Device ID | K962946 |
| 510k Number | K962946 |
| Device Name: | ORTHO-ONE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Contact | James L Sandrik |
| Correspondent | James L Sandrik BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-29 |
| Decision Date | 1996-09-03 |
| Summary: | summary |