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Kavo America

Also registered as Kavo America Corporation

Country not established

Devices
24
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Kavo America makes

Kavo America makes intraoral dental X-ray systems, diagnostic devices such as Diagnodent, dental lasers including Key Laser models, dental handpieces, and dental milling blanks such as Everest C-Temp, TitanBlank, and Zs-Blank models. They also produce prophylaxis products like Prophypearls and dental treatment systems such as Quattrocare and Systematica 1060.

The devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue24

Newest first, rows 1-24 of 24

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  • In Exam Intraoral Dental X-Ray System Ref K050019

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

  • Diagnodent Ref K051909

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

  • Rondoflex Plus 360 Ref K042872

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

  • Kavo Everest C-Temp Ref K063624

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

  • Kavo Everest Titanblank Ref K024214

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

  • Prophypearls Ref K031868

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

  • Kavo Ergocom/Ergocam Ref K050744

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

  • Kavo Everest Zs-Blank Models, 42, 20, And 60 Ref K032081

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

  • Kavo Key Laser 1242 And Kavo Key Laser 1243+ Ref K030146

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

  • Kavo Corund Handpiece 2013 Ref K002708

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

  • Kavo Everest Zh-Blank Ref K033221

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

  • Key Laser Iii 1243 Us With Detect Ref K073074

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

  • Kavo K.E.Y. Laser 1242 Ref K000805

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

  • Kavo Systematica 1060 Ref K940950

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

  • Kavo Quattrocare Ref K012308

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

  • Kavo Key Laser 1242 Ref K983100

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

  • Gentleray 980 Diode Laser System Ref K072262

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

  • Kavo Diagnodent Ref DEN990002

    Active Regimes: De Novo Registry: De Novo Class:II

  • Kavo Intrasept 905 Ref K934783

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

  • Diagnodent Perio Tip (Accessory) Ref K042394

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

  • Kavo Polylux Ii Ref K013500

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

  • Prophyflex 2, Model 2012 Ref K973876

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

  • Kavoklave Steam Autoclave Ref K910789

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

  • Kavo Everest G-Blank, Kavo Everest G-Ceram, Coating Ceramic Lf-3-Pfm, Glaze And Colorings/Staining/Shades Ref K030607

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

Rows 1-24 of 24

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Kavo America, initiated on 2006-11-22. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2006

    • 22 Nov 2006 Z-0289-2007 Unclassified (pre-2012) Terminated The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury. Distribution: Nationwide and Canada Submission number: K012308

Frequently asked questions

How many devices does Kavo America have in the registry?

The registry currently lists 24 devices for Kavo America. Devices recorded under merged duplicate company entries are counted once.

Which registries list Kavo America's devices?

Among its 24 most recently registered devices, Kavo America has devices listed in FDA 510(k) (24 devices).

What risk classes do Kavo America's devices fall under?

Among its 24 most recently registered devices, the classes recorded for Kavo America's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Kavo America?

FDA recall records list 1 recall initiated by Kavo America, the most recent initiated on 22 Nov 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Kavo America in the registry?

The most recently registered devices listed for Kavo America include IN EXAM INTRAORAL DENTAL X-RAY SYSTEM, DIAGNODENT, RONDOFLEX PLUS 360 and KAVO EVEREST C-TEMP.

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