Allesee Orthodontic Appliances, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1000128562
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 1
Catalogue
Fs Aligner Ref K093821
Regimes: 510(k) Registry: 510(k)Red, White & Blue Ref K040874
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000128562
- Address
- 13931 Spring St, Sturtevant, WI, 53177
FDA recalls
2014
- 24 Feb 2014 Z-1314-2014 Class II Terminated The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar, an over-tightened lock nut may stop the piston assembly from moving freely, subsequently preventing intended movement of the teeth.
Frequently asked questions
How many devices does Allesee Orthodontic Appliances, Inc. have in the registry?
The registry currently lists 2 devices for Allesee Orthodontic Appliances, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Allesee Orthodontic Appliances, Inc.'s devices?
Among its 2 most recently registered devices, Allesee Orthodontic Appliances, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Allesee Orthodontic Appliances, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Allesee Orthodontic Appliances, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Allesee Orthodontic Appliances, Inc.?
FDA recall records list 1 recall initiated by Allesee Orthodontic Appliances, Inc., the most recent initiated on 24 Feb 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Allesee Orthodontic Appliances, Inc. in the registry?
The most recently registered devices listed for Allesee Orthodontic Appliances, Inc. include FS ALIGNER and RED, WHITE & BLUE.