Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Kavo America — Predicate Candidate Screening

20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
338 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K073074KEY LASER III 1243 US WITH DETECTKavo America2008-07-102530
K072262GENTLERAY 980 DIODE LASER SYSTEMKavo America2007-10-26720
K063624KAVO EVEREST C-TEMPKavo America2007-02-08640
K051909DIAGNODENTKavo America2005-10-21990
K030146KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+Kavo America2005-08-039310
K050019IN EXAM INTRAORAL DENTAL X-RAY SYSTEMKavo America2005-01-31260
K032081KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60Kavo America2003-07-24170
K031868PROPHYPEARLSKavo America2003-07-09220
K030607KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC Kavo America2003-05-02650
K024214KAVO EVEREST TITANBLANKKavo America2003-03-12820
K012308KAVO QUATTROCAREKavo America2002-06-263381
K013500KAVO POLYLUX IIKavo America2002-01-14840
K002708KAVO CORUND HANDPIECE 2013Kavo America2000-11-28900
K000805KAVO K.E.Y. LASER 1242Kavo America2000-05-04520
DEN990002KAVO DIAGNODENTKavo America2000-02-222250
K983100KAVO KEY LASER 1242Kavo America1999-01-271460
K973876PROPHYFLEX 2, MODEL 2012Kavo America1997-12-19700
K940950KAVO SYSTEMATICA 1060Kavo America1994-12-293040
K934783KAVO INTRASEPT 905Kavo America1994-05-162220
K910789KAVOKLAVE STEAM AUTOCLAVEKavo America1991-08-261820

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda