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Pre-Dent System

Country not established

Devices
3

What Pre-Dent System makes

Pre-Dent System manufactures dental devices designed for intraoral imaging and diagnostic purposes, including modified and original versions of the PRE-DENT SYSTEM. These products are intended for capturing detailed images of dental structures, aiding in treatment planning and diagnostics.

The company’s portfolio is classified under Class I devices in the U.S. and is listed via 510(k) clearance through the FDA. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • Pre-Dent System Modified Ref K801516

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Pre-Dent System Ref K800736

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Pre-Dent System Or Pre-Dent Ii Ref K801386

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

Frequently asked questions

How many devices does Pre-Dent System have in the registry?

The registry currently lists 3 devices for Pre-Dent System. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pre-Dent System's devices?

Among its 3 most recently registered devices, Pre-Dent System has devices listed in FDA 510(k) (3 devices).

What risk classes do Pre-Dent System's devices fall under?

Among its 3 most recently registered devices, the classes recorded for Pre-Dent System's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Pre-Dent System in the registry?

The most recently registered devices listed for Pre-Dent System include PRE-DENT SYSTEM MODIFIED, PRE-DENT SYSTEM and PRE-DENT SYSTEM OR PRE-DENT II.

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