Not currently registered with FDA under this name
Kaltenbach & Voigt GmbH & Co.
Orange, CA, United States. Named as applicant on 2 dental 510(k) clearances between 2008 and 2009. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22008–2009
- Markets registered in
- 26 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Kaltenbach & Voigt GmbH & Co. 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 & Co. | 2 clearances | 2008–2009 | Below |
| South Korea | MFDS | Manufacturer | KALTENBACH & VOIGT GmbH & Co.Kaltenbach & Voigt GmbH & Co.KG · Kaltenbach & Voigt GmbH & Co. KG | 6 | 2001–2012 | 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 & Co. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Nov 2009 | K092446 | INTRA LUX HEAD 3 LDSY | EFA Dental Belt and/or Gear Driven Handpiece |
| 6 Jun 2008 | K080677 | COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE | EIA Operative Dental Unit |
Some of these clearances are listed with FDA today by another company: KaVo Dental GmbH (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.