The following data is part of a premarket notification filed by Ortho Specialties with the FDA for Composite Orthodontic Brackets.
| Device ID | K140807 |
| 510k Number | K140807 |
| Device Name: | COMPOSITE ORTHODONTIC BRACKETS |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | ORTHO SPECIALTIES 207 PHEASANT MEADOW CT. Gurnee, IL 60031 |
| Contact | Paula Wendland |
| Correspondent | Paula Wendland ORTHO SPECIALTIES 207 PHEASANT MEADOW CT. Gurnee, IL 60031 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-11-12 |
| Summary: | summary |