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Ultradent Products Inc. / Oratech, LLC

United StatesFDA applicant, unverified

Devices
2

Catalogue2

Newest first, rows 1-2 of 2

  • Ultracem Ref K132255

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Enamelast Ref K132109

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Ultradent Products Inc. / Oratech, LLC have in the registry?

The registry currently lists 2 devices for Ultradent Products Inc. / Oratech, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ultradent Products Inc. / Oratech, LLC's devices?

Among its 2 most recently registered devices, Ultradent Products Inc. / Oratech, LLC has devices listed in FDA 510(k) (2 devices).

What risk classes do Ultradent Products Inc. / Oratech, LLC's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Ultradent Products Inc. / Oratech, LLC's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Ultradent Products Inc. / Oratech, LLC in the registry?

The most recently registered devices listed for Ultradent Products Inc. / Oratech, LLC include ULTRACEM and ENAMELAST.

Generated automatically from registry data and not verified by a human reviewer.