Medental Intl.
United Statesfrom the FDA registration address FDA FEI 3001236822
- Devices
- 7
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Medental Intl. makes
Medental Intl. manufactures dental restorative materials including chemical cure composites with enamel bond, cavity varnishes, chemical curing sealants for pit and fissure, multi-cure composite cements, polycarboxylate cement, and glass ionomer cement types I and MIRAGE.
The company's products are classified as Class II medical devices and are listed in the FDA 510(k) registry. Medental Intl. is based in the US.
Catalogue
Zinc Phosphate Cement Ref K983018
Regimes: 510(k) Registry: 510(k)Chemical Cure Composite With Enamel Bond Ref K982191
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Multi-Cure Composite Cement Ref K990314
Regimes: 510(k) Registry: 510(k)Polycarboxylate Cement Ref K980990
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3001236822
- Address
- 3008 PALM HILL DR., VISTA, CA, 92084
Frequently asked questions
How many devices does Medental Intl. have in the registry?
The registry currently lists 7 devices for Medental Intl.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medental Intl.'s devices?
Among its 7 most recently registered devices, Medental Intl. has devices listed in FDA 510(k) (7 devices).
What risk classes do Medental Intl.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Medental Intl.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medental Intl. in the registry?
The most recently registered devices listed for Medental Intl. include ZINC PHOSPHATE CEMENT, CHEMICAL CURE COMPOSITE WITH ENAMEL BOND, CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) and MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED.