Retainer, Screw Expansion, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (5 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in DYJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Brius Technologies Inc. | 0 | 3 |
| A Company, Inc. | 1 | 0 |
| Allesee Orthodontic Appliances | 0 | 1 |
| American Orthodontics | 1 | 0 |
| Cleft Palate Appliances, Inc. | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Forestadent | 1 | 0 |
| Ormco Corporation | 0 | 1 |
| Sybron Dental Specialties | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2022 | Brius Technologies Inc. Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL Terminated |
DYJ | None listed |
| Feb 7, 2022 | Brius Technologies Inc. Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL Terminated |
DYJ | None listed |
| Feb 7, 2022 | Brius Technologies Inc. Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL Terminated |
DYJ | None listed |
| Apr 1, 2014 | Allesee Orthodontic Appliances AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaw Terminated |
DYJ | None listed |
| Sep 12, 2013 | Sybron Dental Specialties AOA Mini RPE Screw Assembly , a component of
Herbst, MARA and Fixed Metal devices.
Product Usage:
AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functio Terminated |
DYJ | None listed |
| Mar 5, 2012 | Ormco Corporation AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by this recall are as follows:
Part Number: Terminated |
DYJ | None listed |
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