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

Coltène/Whaledent AG — Predicate Candidate Screening

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

97 daysmedian FDA review time

221 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K220097	PRESIDENT The Original	Coltène/Whaledent AG	2022-01-13	1
K191385	BRILLIANT COMPONEER	Coltene/Whaledent AG	2019-10-29	159
K190597	BRILLIANT EverGlow Flow	Coltene/Whaledent AG	2019-06-21	106
K181500	BRILLIANT Crios	Coltene/Whaledent AG	2018-08-15	69
K160800	DuoCem	Coltene/Whaledent AG	2016-11-16	238
K152927	BRILLIANT EVERGLOW	Coltene/Whaledent AG	2016-04-28	206
K152243	One Coat 7 Universal	Coltene/Whaledent AG	2015-12-09	121
K150218	Fill-Up!	Coltene/Whaledent AG	2015-06-23	144
K121621	SOLOCEM	Coltene/Whaledent AG	2013-01-08	221
K112168	COMPONEER	Coltene/Whaledent AG	2011-11-21	116
K083304	TEMPOSIL 2	Coltene/Whaledent AG	2009-02-06	88
K072604	DUO TEMP	Coltene/Whaledent AG	2007-11-16	60
K052820	PARAPOST PARACORE AUTOMIX 5ML	Coltene/Whaledent AG	2006-01-09	97
K053040	PARACEM UNIVERSAL DC	Coltene/Whaledent AG	2005-11-09	13
K051243	JET BLUE BITE	Coltene/Whaledent AG	2005-06-23	41
K050426	TEMPOSIL, MODEL 6720	Coltene/Whaledent AG	2005-03-18	28
K050013	RETRACTOFOAM	Coltene/Whaledent AG	2005-02-09	37

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