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

Cavex Holland BV · Predicate Candidate Screening

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

58 daysmedian FDA review time

92 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K151535	Cavex Cream Alginate	Cavex Holland BV	2015-10-28	142
K141092	MARK3	Cavex Holland BV	2014-12-04	220
K073539	PROVISA CEM	Cavex Holland BV	2008-01-31	45
K072245	EMULATE ADVANCED	Cavex Holland BV	2007-11-08	87
K062400	IMPRESSIX, COLORCHANGE ALGINATE	Cavex Holland BV	2006-11-16	92
K061267	SIMULATE, COLOR CHANGE ALGINATE	Cavex Holland BV	2006-07-10	66
K052455	IMPRESSIX	Cavex Holland BV	2005-11-23	77
K051207	CAVEX ORTHOTRACE	Cavex Holland BV	2005-06-21	41
K042806	QUADRANT UNIT-1-BOND	Cavex Holland BV	2004-11-24	43
K032116	TULIP COLORSWITCH	Cavex Holland BV	2003-09-30	83
K023466	TULIP ALGINATE IMPRESSION MATERIAL	Cavex Holland BV	2002-12-13	58
K020242	EMULATE FAST SET AND EMULATE REGULAR SET	Cavex Holland BV	2002-04-17	84
K013336	XANTALGIN CRONO	Cavex Holland BV	2001-10-29	20
K011452	CAVEX STABISIL	Cavex Holland BV	2001-07-19	69
K011419	CAVEX COLORCHANGE	Cavex Holland BV	2001-07-16	68
K003791	CAVEX TEMPORARY CEMENT	Cavex Holland BV	2001-01-23	46
K000686	KROM-ALGINATE AND ALGINATE PLUS	Cavex Holland BV	2000-05-25	86
K984044	QUADRANT POSTERIOR DENSE	Cavex Holland BV	1998-12-16	33
K984043	QUADRANT TOTAL ETCH	Cavex Holland BV	1998-12-04	21
K984042	QUADRANT CORE LC	Cavex Holland BV	1998-12-04	21
K984041	QUADRANT UNIVERSAL LC	Cavex Holland BV	1998-12-04	21
K983751	QUADRANT UNICHEM	Cavex Holland BV	1998-11-30	38
K983549	QUADRANT ANTERIOR SHINE	Cavex Holland BV	1998-11-23	45
K983545	QUADRANT UNIBOND	Cavex Holland BV	1998-11-18	40
K981970	ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST S	Cavex Holland BV	1998-09-02	90
K980965	SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL	Cavex Holland BV	1998-05-01	46

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