Makeo Healthcare Technologies Private Limited
IndiaFDA applicant, unverified
- Devices
- 1
What Makeo Healthcare Technologies Private Limited makes
Makeo Healthcare Technologies Private Limited manufactures dental alignment systems, including removable orthodontic appliances like Smilealigners and tooth-positioning devices such as Toothsi. These products are designed for over-the-counter or professional use in correcting minor dental misalignments.
The company’s portfolio is regulated under FDA Class II devices, requiring 510(k) clearance for market authorisation. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Toothsi, Smilealigners Ref K223338
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Makeo Healthcare Technologies Private Limited have in the registry?
The registry currently lists 1 device for Makeo Healthcare Technologies Private Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Makeo Healthcare Technologies Private Limited's devices?
Among its 1 most recently registered device, Makeo Healthcare Technologies Private Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Makeo Healthcare Technologies Private Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Makeo Healthcare Technologies Private Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Makeo Healthcare Technologies Private Limited in the registry?
The most recently registered devices listed for Makeo Healthcare Technologies Private Limited include Toothsi, Smilealigners.