Dentamax, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Dentamax, Inc. makes
Dentamax, Inc. manufactures orthodontic accessories, including removable retainers like THE.R.MO.FREE and preformed clasps made from acetal resin for dental appliances. These products are designed to support dental retention and stability in fixed or removable orthodontic treatments.
The company’s devices are regulated under FDA Class I and Class II classifications, with some products requiring 510(k) clearance. They are listed in the FDA’s 510(k) database, adhering to U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
The.r.mo.free Ref K990448
Regimes: 510(k) Registry: 510(k)Acetal Dental/Preformed Clasp Ref K983558
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dentamax, Inc. have in the registry?
The registry currently lists 2 devices for Dentamax, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dentamax, Inc.'s devices?
Among its 2 most recently registered devices, Dentamax, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Dentamax, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dentamax, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dentamax, Inc. in the registry?
The most recently registered devices listed for Dentamax, Inc. include THE.R.MO.FREE and ACETAL DENTAL/PREFORMED CLASP.