Not currently registered with FDA under this name
Kaltenbach & Voigt GmbH
Biberach, Germany. Named as applicant on 9 dental 510(k) clearances between 2011 and 2019. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 92011–2019
- Markets registered in
- 8142 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Kaltenbach & Voigt GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Kaltenbach & Voigt GmbH | 9 clearances | 2011–2019 | Below |
| Saudi Arabia | SFDA | Manufacturer | Kaltenbach & Voigt GmbH | 60 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KALTENBACH & VOIGT GMBH | 36 | 2005–2020 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Kaltenbach & Voigt GmbHKaltenbach &Voigt GmbH · Kaltenbach & Voigt GmbH, | 13 | 2003–2013 | Pure Global AI |
| Colombia | INVIMA | Registration holder | KALTENBACH & VOIGT GMBH | 12 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | KALTENBACH & VOIGT GMBH | 12 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Kaltenbach & Voigt GmbH | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Kaltenbach & Voigt GmbH | 3 | 2011–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Kaltenbach & Voigt GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Nov 2019 | K182712 | DEXIS CariVu 3-in-1 by KaVo | NTK Light Transmission Caries Detector |
| 10 Apr 2019 | K181110 | PROPHYflex 4 | EFB Dental Air-Powered Handpiece |
| 17 Mar 2017 | K163239 | SMARTmatic | EFA Dental Belt and/or Gear Driven Handpiece |
| 8 Dec 2016 | K161488 | ESTETICA Dental Treatment Unit and Accessories | EIA Operative Dental Unit |
| 9 Apr 2015 | K143465 | MASTERmatic LUX | EFA Dental Belt and/or Gear Driven Handpiece |
| 15 Aug 2014 | K140308 | MASTERSURG / EXPERTSURG | EBW Handpiece and Cord Foot Controller |
| 27 Sep 2013 | K130560 | MASTERTORQUE LUX 8900 L | EFB Dental Air-Powered Handpiece |
| 24 Sep 2013 | K123402 | DIAGNOCAM | NTK Light Transmission Caries Detector |
| 19 Aug 2011 | K103027 | ELECTROTORQUE TLC | EBW Handpiece and Cord Foot Controller |
Some of these clearances are listed with FDA today by another company: KaVo Dental GmbH (8), A-dec, Inc. (4), Sybron Dental Specialties (1), Nobel Biocare Services AG (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.