Stephen J Harkins, Dds, PC
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- Devices
- 1
What Stephen J Harkins, Dds, PC makes
Stephen J Harkins, DDS, PC manufactures the Twilite Appliance, a dental device designed for orthodontic treatment, likely used in nighttime wear for gradual tooth alignment or repositioning.
The Twilite Appliance is classified as a Class II medical device in the US and is listed under FDA’s 510(k) pathway. The manufacturer operates from the United States.
Catalogue
Twilite Appliance Ref K190687
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stephen J Harkins, Dds, PC have in the registry?
The registry currently lists 1 device for Stephen J Harkins, Dds, PC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stephen J Harkins, Dds, PC's devices?
Among its 1 most recently registered device, Stephen J Harkins, Dds, PC has devices listed in FDA 510(k) (1 device).
What risk classes do Stephen J Harkins, Dds, PC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Stephen J Harkins, Dds, PC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stephen J Harkins, Dds, PC in the registry?
The most recently registered devices listed for Stephen J Harkins, Dds, PC include Twilite Appliance.