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Data / Medical devices / Germany / Kavo Dental GMBH

Kavo Dental GMBH: FDA-registered device maker in WARTHAUSEN Baden-Wurttemberg, Germany, 21 510(k) clearances

Kavo Dental GMBH is registered with the FDA (registration 3003637274) in WARTHAUSEN Baden-Wurttemberg, Germany. It lists 20 device types. The FDA files 21 510(k) clearances under its listings, the newest dated December 21, 2021. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Kavo Dental GMBH
FDA registration number
3003637274
Address
Bahnhofstrasse 20, WARTHAUSEN Baden-Wurttemberg, Germany, 88447
Owner or operator
KaVo Dental GmbH (10042139)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
October 24, 2012
Registered through
2026
Brand names listed
0.411.9650 - KaVo Spray AMERICA 2113, 0.411.9660 - KaVo Spray AMERICA 2113 (Set), 0.535.5200 - INTRA-L-MOTOR 181 H, 0.535.5210 - INTRA L-LUX 181 L, 0.535.5250 - INTRAmatic 181 M, 0.535.5260 - INTRA 181 K 20 000 R.P.M., 0.535.6180 - INTRAflex LUX2 2320 LN, 0.535.6190 - INTRAflex LUX2 2307 LN and more

Devices it lists

DeviceProduct codeClassRoleSource
Activator, Ultraviolet, For PolymerizationEBZ2Exporter to the USaccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Manufacturer, Specification developeraccessdata.fda.gov
AirbrushKOJ2Manufactureraccessdata.fda.gov
ArticulatorsEJP1Manufactureraccessdata.fda.gov
Controller, Foot, Handpiece And CordEBW1Manufactureraccessdata.fda.gov
Device, Jaw Tracking, For Monitoring Jaw PositionsNFS1Exporter to the USaccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Contract manufacturer, Manufactureraccessdata.fda.gov
Handpiece, Belt And/Or Gear Driven, DentalEFA1Manufactureraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Manufactureraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Manufactureraccessdata.fda.gov
Light Transmission Caries DetectorNTK2Manufactureraccessdata.fda.gov
Light, Operating, DentalEAZ1Manufactureraccessdata.fda.gov
Light-Induced Fluorescence Caries Detector NBL2Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufacturer, Specification developeraccessdata.fda.gov
Remover, CrownEIS1Manufactureraccessdata.fda.gov
Scaler, UltrasonicELC2Exporter to the US, Manufactureraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Manufactureraccessdata.fda.gov
Unit, Operative DentalEIA1Manufactureraccessdata.fda.gov
Unit, Oral IrrigationEFS1Exporter to the USaccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 21, 2021K213139SURGmatic S15 L ProEGSSubstantially EquivalentKavo Dental GmbHaccessdata.fda.gov
November 23, 2019K182712DEXIS CariVu 3-in-1 by KaVoNTKSubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
April 10, 2019K181110PROPHYflex 4EFBSubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
March 17, 2017K163239SMARTmaticEFASubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
February 21, 2017K163317ELECTROmaticEBWSubstantially EquivalentKaltenbach & Voigt Gmghaccessdata.fda.gov
April 9, 2015K143465MASTERmatic LUXEFASubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
February 27, 2015K140990EMS PIEZON 707 BIK AND PIEZON 707 BIK LEDELCSubstantially EquivalentE.M.S Electro Medical Systems S.Aaccessdata.fda.gov
August 15, 2014K140308MASTERSURG / EXPERTSURGEBWSubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
September 24, 2013K123402DIAGNOCAMNTKSubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
August 19, 2011K103027ELECTROTORQUE TLCEBWSubstantially EquivalentKaltenbach & Voigt GmbHaccessdata.fda.gov
October 14, 2009K091091SONICFILL 2010EBFSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
September 4, 2008K080089SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPSELCSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
September 3, 2008K073478SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTSEFBSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
June 6, 2008K080677COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECEEIASubstantially EquivalentKaltenbach & Voigt GmbH & Co.accessdata.fda.gov
July 19, 2007K071288MODIFICATION TO KAVO QUATTROCAREEBFSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
February 8, 2006K060080DIAGNODENT 2190 WITH PERIODONTAL PROBENTKSubstantially EquivalentKavo Dental Corporationaccessdata.fda.gov
August 2, 2005K042394DIAGNODENT PERIO TIP (ACCESSORY)NBLSubstantially EquivalentKavo America Corporationaccessdata.fda.gov
November 23, 2004K042872RONDOFLEX PLUS 360KOJSubstantially EquivalentKavo America Corporationaccessdata.fda.gov
October 21, 2003K032465MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINIEBZSubstantially EquivalentSatelecaccessdata.fda.gov
July 9, 2003K031868PROPHYPEARLSEFBSubstantially EquivalentKavo Americaaccessdata.fda.gov
February 22, 2000DEN990002KAVO DIAGNODENTNBLUnknownKavo Americaaccessdata.fda.gov

Compare with other makers

Updated December 21, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.