Advanced Facialdontics, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Advanced Facialdontics, LLC makes
Advanced Facialdontics, LLC manufactures orthodontic appliances, including The NightBlocks Appliance—a device designed for nighttime use—and The POD, a removable intraoral appliance for dental alignment or stabilization.
The company’s products are regulated under FDA Class II and Class U device classifications, with submissions supported via 510(k) pathways. The devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
The NightBlocks Appliance Ref K192581
Regimes: 510(k) Registry: 510(k)The POD Ref K182820
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Advanced Facialdontics, LLC have in the registry?
The registry currently lists 2 devices for Advanced Facialdontics, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Facialdontics, LLC's devices?
Among its 2 most recently registered devices, Advanced Facialdontics, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Advanced Facialdontics, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Advanced Facialdontics, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Facialdontics, LLC in the registry?
The most recently registered devices listed for Advanced Facialdontics, LLC include The NightBlocks Appliance and The POD.