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3D Diagnostix, Inc.

United StatesFDA applicant, unverified

Devices
85

What 3D Diagnostix, Inc. makes

3D Diagnostix, Inc. manufactures reusable dental and maxillofacial surgical tools, including drill bits, drilling template guides and sleeves, surgical procedure kits, chuck keys, soft-tissue punches, custom-made drilling templates, and reusable mouthguards and orthodontic retainers.

The company’s products are regulated under FDA classifications including Class I, Class II, and Unclassified (U), with submissions recorded in the FDA’s 510(k) and UDI registries. The manufacturer is based in the United States.

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

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Company details

DUNS number
004512027

Frequently asked questions

How many devices does 3D DIAGNOSTIX, INC. have in the registry?

The registry currently lists 85 devices for 3D DIAGNOSTIX, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list 3D DIAGNOSTIX, INC.'s devices?

Among its 50 most recently registered devices, 3D DIAGNOSTIX, INC. has devices listed in FDA GUDID (50 devices).

What risk classes do 3D DIAGNOSTIX, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for 3D DIAGNOSTIX, INC.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from 3D DIAGNOSTIX, INC. in the registry?

The most recently registered devices listed for 3D DIAGNOSTIX, INC. include AOX 3DDX Kit, 3DDX Sleeve 510-415-35L, 3DDX Sleeve 565-465-4L and Tapered Drill 3.45X18 - White.

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