Dental Therapeutics AB
SwedenFDA applicant, unverified
- Devices
- 2
What Dental Therapeutics AB makes
Dental Therapeutics AB manufactures dental materials used in endodontic procedures, including the TUBULITEC PRIMER and TUBULITEC LINER, which are designed for root canal treatments and dental pulp therapy.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Tubulitec Primer Ref K851052
Regimes: 510(k) Registry: 510(k)Tubulitec Liner Ref K851053
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dental Therapeutics AB have in the registry?
The registry currently lists 2 devices for Dental Therapeutics AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dental Therapeutics AB's devices?
Among its 2 most recently registered devices, Dental Therapeutics AB has devices listed in FDA 510(k) (2 devices).
What risk classes do Dental Therapeutics AB's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dental Therapeutics AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dental Therapeutics AB in the registry?
The most recently registered devices listed for Dental Therapeutics AB include TUBULITEC PRIMER and TUBULITEC LINER.