Data / Medical devices / Germany / Kavo Dental GMBH
Kavo Dental GMBH: FDA-registered device maker in BIBERACH Baden-Wurttemberg, Germany, 3 510(k) clearances
Kavo Dental GMBH is registered with the FDA (registration 8010493) in BIBERACH Baden-Wurttemberg, Germany. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 21, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8010493
- FEI number
- 1344
- Address
- Bismarckring 39, BIBERACH Baden-Wurttemberg, Germany, 88400
- Owner or operator
- KaVo Dental GmbH (10042139)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 24, 2012
- Registered through
- 2026
- Brand names listed
- 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, 0.535.6200 - INTRAflex LUX2 2329 LN, 0.535.6210 - INTRAflex LUX2 2325 LN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Controller, Foot, Handpiece And Cord | EBW | 1 | Specification developer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 21, 2017 | K163317 | ELECTROmatic | EBW | Substantially Equivalent | Kaltenbach & Voigt Gmgh | accessdata.fda.gov |
| September 27, 2013 | K130560 | MASTERTORQUE LUX 8900 L | EFB | Substantially Equivalent | Kaltenbach & Voigt GmbH | accessdata.fda.gov |
| September 3, 2008 | K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | EFB | Substantially Equivalent | Sybron Dental Specialties, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 21, 2017. 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.