Kavo America
Lake Zurich, IL, US
Kavo America appears in FDA device records in Lake Zurich, IL. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Kavo America between 1991 and 2008. The busiest year on record is 2003, with 5. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1994 | 2 |
| 1997 | 1 |
| 1999 | 1 |
| 2000 | 3 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 1 |
| 2005 | 5 |
| 2007 | 2 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K073074 | KEY LASER III 1243 US WITH DETECT | GEX | Substantially Equivalent | |
| K072262 | GENTLERAY 980 DIODE LASER SYSTEM | GEX | Substantially Equivalent | |
| K063624 | KAVO EVEREST C-TEMP | EBG | Substantially Equivalent | |
| K051909 | DIAGNODENT | NBL | Substantially Equivalent | |
| K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ | NVK | Substantially Equivalent | |
| K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | NBL | Substantially Equivalent | |
| K050744 | KAVO ERGOCOM/ERGOCAM | LLZ | Substantially Equivalent | |
| K050019 | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM | EHD | Substantially Equivalent | |
| K042872 | RONDOFLEX PLUS 360 | KOJ | Substantially Equivalent | |
| K033221 | KAVO EVEREST ZH-BLANK | EIH | Substantially Equivalent | |
| K032081 | KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 | EIH | Substantially Equivalent | |
| K031868 | PROPHYPEARLS | EFB | Substantially Equivalent | |
| K030607 | KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES | EIH | Substantially Equivalent | |
| K024214 | KAVO EVEREST TITANBLANK | EJH | Substantially Equivalent | |
| K012308 | KAVO QUATTROCARE | EFB | Substantially Equivalent | |
| K013500 | KAVO POLYLUX II | EBZ | Substantially Equivalent | |
| K002708 | KAVO CORUND HANDPIECE 2013 | KOJ | Substantially Equivalent | |
| K000805 | KAVO K.E.Y. LASER 1242 | GEX | Substantially Equivalent | |
| DEN990002 | KAVO DIAGNODENT | NBL | Unknown | |
| K983100 | KAVO KEY LASER 1242 | GEX | Substantially Equivalent | |
| K973876 | PROPHYFLEX 2, MODEL 2012 | EFB | Substantially Equivalent | |
| K940950 | KAVO SYSTEMATICA 1060 | KLC | Substantially Equivalent | |
| K934783 | KAVO INTRASEPT 905 | EIA | Substantially Equivalent | |
| K910789 | KAVOKLAVE STEAM AUTOCLAVE | FLE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- KOJAirbrush
- EJHAlloy, Metal, Base
- KLCChair, Dental, With Operative Unit
- EBGCrown And Bridge, Temporary, Resin
- EFBHandpiece, Air-Powered, Dental
- NVKLaser, Dental, Soft Tissue
- NBLLight-Induced Fluorescence Caries Detector
- EIHPowder, Porcelain
- GEXPowered Laser Surgical Instrument
- FLESterilizer, Steam
- LLZSystem, Image Processing, Radiological
- EIAUnit, Operative Dental
- EHDUnit, X-Ray, Extraoral With Timer
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0289-2007 | KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUATTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUATTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUATTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain