The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Solo Ortho 3.
| Device ID | K020502 |
| 510k Number | K020502 |
| Device Name: | SOLO ORTHO 3 |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-14 |
| Decision Date | 2002-05-01 |
| Summary: | summary |