Thermoelastic Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Thermoelastic Technologies, Inc. makes
Thermoelastic Technologies, Inc. manufactures dental orthodontic and occlusal adjustment kits, including the Bitem Angel Reline Kit and Bitem Laboratory Kit for intraoral and laboratory use. Their product line also includes the Bitem Lock, designed for securing orthodontic appliances, available in multiple sizes.
These devices are classified as Class I and Class II under FDA regulations, with some models requiring 510(k) clearance. The company’s products are listed in the FDA’s 510(k) registry. Thermoelastic Technologies, Inc. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Bitem Lock, Models SW006, SW012 Ref K994357
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Thermoelastic Technologies, Inc. have in the registry?
The registry currently lists 2 devices for Thermoelastic Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Thermoelastic Technologies, Inc.'s devices?
Among its 2 most recently registered devices, Thermoelastic Technologies, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Thermoelastic Technologies, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Thermoelastic Technologies, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Thermoelastic Technologies, Inc. in the registry?
The most recently registered devices listed for Thermoelastic Technologies, Inc. include BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 and BITEM LOCK, MODELS SW006, SW012.