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Addent, Inc.

United StatesFDA applicant, unverified FDA FEI 3003694926

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

Devices
13
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA 510(k) 7
  • FDA GUDID 6

A device listed in two registries counts in both.

Device classes
  • FDA Class II 8
  • FDA Class I 5
Identifiers
  • FDA FEI 3003694926
  • DUNS 099490679

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

What Addent, Inc. makes

Addent, Inc. manufactures dental and oral healthcare devices, including fibreoptic dental lights for examination and treatment, such as transilluminators and examination lights like the MICROLUX series. The company also produces anaesthesia warmers, including composite heaters like the CALSET, and diagnostic tools like toluidine blue O solution for oral lesion examination. Additional products include high-definition imaging systems, such as the Compex HD, for intraoral assessments.

The company’s devices are regulated under FDA classifications, with most falling under Class I and Class II. Products are authorised via the 510(k) pathway and listed in the FDA’s Unique Device Identifier (UDI) database.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

Newest first, rows 1-13 of 13

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  • AdDent Compex HD

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

  • AdDent OraBlu

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

  • AdDent Microlux

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

  • AdDent Calset

    Listed Registry: GUDID Class:I

  • AdDent Bio/Screen

    Listed Registry: GUDID Class:II

  • AdDent Microlux 2

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

  • Microlux/Dl Microlux/Blu Bio/Screen Ref K121282

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

  • Bio-Screen Ref K082668

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

  • Microlux Dl Ref K041614

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

  • Calset Composite Heater Ref K061395

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

  • Microlux Transilluminator Ref K062961

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

  • Compex HD Ref K182017

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

  • Microlux/Blu Ref K072309

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

Rows 1-13 of 13

Company details

FDA FEI number
3003694926
DUNS number
099490679
Address
43 Miry Brook Rd, DANBURY, CT, 06810
Phone
2037780200

Frequently asked questions

How many devices does Addent, Inc. have in the registry?

The registry currently lists 13 devices for Addent, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Addent, Inc.'s devices?

Among its 13 most recently registered devices, Addent, Inc. has devices listed in FDA 510(k) (7 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Addent, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Addent, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Addent, Inc. in the registry?

The most recently registered devices listed for Addent, Inc. include AdDent Compex HD, AdDent OraBlu, AdDent Microlux and AdDent Calset.

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