European Dental Imports, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What European Dental Imports, Inc. makes
European Dental Imports, Inc. manufactures dental alloys and porcelain systems for restorative and prosthetic applications, including high-strength casting alloys (e.g., ORION VESTA, BIOGOLD PLUS) and porcelain materials (e.g., ANTAGON, CARRARA series) for crowns, bridges, and inlays.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Orion Vesta Dental Alloy Ref K981001
Regimes: 510(k) Registry: 510(k)Cera E Dental Alloy Ref K980661
Regimes: 510(k) Registry: 510(k)Biogold Plus Dental Alloy Ref K980660
Regimes: 510(k) Registry: 510(k)Antagon Porcelain Ref K982129
Regimes: 510(k) Registry: 510(k)Orion Wx Dental Alloy Ref K981002
Regimes: 510(k) Registry: 510(k)Carrara Pdf, Carrara H, Carrara R Ref K980597
Regimes: 510(k) Registry: 510(k)Carrara Porcelain And Carrara Vincent Porcelain Ref K981000
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does European Dental Imports, Inc. have in the registry?
The registry currently lists 7 devices for European Dental Imports, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list European Dental Imports, Inc.'s devices?
Among its 7 most recently registered devices, European Dental Imports, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do European Dental Imports, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for European Dental Imports, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from European Dental Imports, Inc. in the registry?
The most recently registered devices listed for European Dental Imports, Inc. include ORION VESTA DENTAL ALLOY, CERA E DENTAL ALLOY, BIOGOLD PLUS DENTAL ALLOY and ANTAGON PORCELAIN.