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Dentalez, Inc.

United StatesFDA applicant, unverified

Dentalez, Inc. is a medical device manufacturer, with 238 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) as of 13 Nov 2026.

Devices
238

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 231
  • FDA 510(k) 7

A device listed in two registries counts in both.

Device classes
  • FDA Class I 215
  • FDA Class II 23
Identifiers
  • DUNS 059010363

What Dentalez, Inc. makes

Dentalez, Inc. manufactures dental surgical power tools, including pneumatic and electric motorized handpieces, as well as reusable diamond burs and periodontal curettes. Their product line also includes motorless handpiece components, reusable dental probes, and pneumatic scaling/debridement tips for periodontal treatment. These tools are designed for dental procedures requiring precision cutting, scaling, or probing.

The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. Products are listed in the FDA’s 510(k) and UDI registries, ensuring compliance with U.S. medical device regulations.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue238

Newest first, rows 1-50 of 238

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Company details

DUNS number
059010363
Phone
1-866-383-4636

Frequently asked questions

How many devices does DENTALEZ, INC. have in the registry?

The registry currently lists 238 devices for DENTALEZ, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list DENTALEZ, INC.'s devices?

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

What risk classes do DENTALEZ, INC.'s devices fall under?

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

What are the newest devices from DENTALEZ, INC. in the registry?

The most recently registered devices listed for DENTALEZ, INC. include StarDental 266340, StarDental 266341, StarDental 266346 and StarDental 266347.

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