Company ยท US
Kavo America
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2008. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 4 |
| GEX | Powered Laser Surgical Instrument | 4 |
| EIH | Powder, Porcelain | 3 |
| NBL | Light-Induced Fluorescence Caries Detector | 3 |
| KOJ | Airbrush | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 |
| EIA | Unit, Operative Dental | 1 |
| EJH | Alloy, Metal, Base | 1 |
| FLE | Sterilizer, Steam | 1 |
| KLC | Chair, Dental, With Operative Unit | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| NVK | Laser, Dental, Soft Tissue | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2008 | K073074 | KEY LASER III 1243 US WITH DETECT Kavo America | GEX |
| Oct 26, 2007 | K072262 | GENTLERAY 980 DIODE LASER SYSTEM Kavo America | GEX |
| Feb 8, 2007 | K063624 | KAVO EVEREST C-TEMP Kavo America | EBG |
| Oct 21, 2005 | K051909 | DIAGNODENT Kavo America | NBL |
| Aug 3, 2005 | K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ Kavo America | NVK |
| Aug 2, 2005 | K042394 | DIAGNODENT PERIO TIP (ACCESSORY) Kavo America Corporation | NBL |
| Apr 21, 2005 | K050744 | KAVO ERGOCOM/ERGOCAM Kavo America Corporation | LLZ |
| Jan 31, 2005 | K050019 | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM Kavo America | EHD |
| Nov 23, 2004 | K042872 | RONDOFLEX PLUS 360 Kavo America Corporation | KOJ |
| Oct 28, 2003 | K033221 | KAVO EVEREST ZH-BLANK Kavo America Corporation | EIH |
| Jul 24, 2003 | K032081 | KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 Kavo America | EIH |
| Jul 9, 2003 | K031868 | PROPHYPEARLS Kavo America | EFB |
| May 2, 2003 | K030607 | KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES Kavo America | EIH |
| Mar 12, 2003 | K024214 | KAVO EVEREST TITANBLANK Kavo America | EJH |
| Jun 26, 2002 | K012308 | KAVO QUATTROCARE Kavo America | EFB |
| Jan 14, 2002 | K013500 | KAVO POLYLUX II Kavo America | EBZ |
| Nov 28, 2000 | K002708 | KAVO CORUND HANDPIECE 2013 Kavo America | KOJ |
| May 4, 2000 | K000805 | KAVO K.E.Y. LASER 1242 Kavo America | GEX |
| Feb 22, 2000 | DEN990002 | KAVO DIAGNODENT Kavo America | NBL |
| Jan 27, 1999 | K983100 | KAVO KEY LASER 1242 Kavo America | GEX |
| Dec 19, 1997 | K973876 | PROPHYFLEX 2, MODEL 2012 Kavo America | EFB |
| Dec 29, 1994 | K940950 | KAVO SYSTEMATICA 1060 Kavo America | KLC |
| May 16, 1994 | K934783 | KAVO INTRASEPT 905 Kavo America | EIA |
| Aug 26, 1991 | K910789 | KAVOKLAVE STEAM AUTOCLAVE Kavo America | FLE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2006 | Kavo America Corporation 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 maintenanc Terminated |
EFB | K012308 |