New England Ortho Lab, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What New England Ortho Lab, Inc. makes
New England Ortho Lab, Inc. manufactures dental clear aligners designed for orthodontic treatment, including custom-fitted aligners used to gradually reposition teeth.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) database.
Catalogue
NEOLab Clear Aligners Ref K192338
Regimes: 510(k) Registry: 510(k)NEOLab Clear Aligners Ref K203339
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does New England Ortho Lab, Inc. have in the registry?
The registry currently lists 2 devices for New England Ortho Lab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New England Ortho Lab, Inc.'s devices?
Among its 2 most recently registered devices, New England Ortho Lab, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do New England Ortho Lab, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for New England Ortho Lab, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from New England Ortho Lab, Inc. in the registry?
The most recently registered devices listed for New England Ortho Lab, Inc. include NEOLab Clear Aligners.