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

Kerr Corporation — Predicate Candidate Screening

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

90 daysmedian FDA review time

163 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252890	ZenSeal Pro	Kerr Corporation	2026-01-07	118	0
K222830	Rainbow 360	Kerr Corporation	2023-01-12	115	0
K221255	SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow	Kerr Corporation	2022-08-31	121	0
K191548	Nexus Universal Self-Cure	Kerr Corporation	2019-10-11	121	0
K182162	OptiBond eXTRa Universal	Kerr Corporation	2018-11-07	89	0
K162948	Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chlori	Kerr Corporation	2017-08-08	291	0
K163064	Demi Ultra	Kerr Corporation	2017-07-18	258	0
K162536	GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+	Kerr Corporation	2017-02-03	144	0
K162164	GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-I	Kerr Corporation	2017-01-13	163	0
K162436	EndoVac Pure	Kerr Corporation	2016-12-21	112	0
K162257	P1145 Dental Restorative	Kerr Corporation	2016-11-07	88	0
K160441	Identic and KromaFaze Alginate Dental Impression Materials	Kerr Corporation	2016-06-30	134	0
K123468	DEMI ULTRA	Kerr Corporation	2013-03-20	131	0
K123595	NEXUS RMGI	Kerr Corporation	2013-02-19	90	0
K110747	TEMPFLEX	Kerr Corporation	2011-06-14	89	0
K110092	TAKE 1 ADVANCED RIGID TRAY	Kerr Corporation	2011-04-08	86	0
K102621	SOLSTICE	Kerr Corporation	2011-01-28	137	0
K103351	DMC COMPOSITE 2	Kerr Corporation	2011-01-20	65	0
K101756	TSC	Kerr Corporation	2010-10-26	125	0
K102163	REALSEAL XT SEALER	Kerr Corporation	2010-10-16	75	0
K102133	GIRAFFE2	Kerr Corporation	2010-10-07	70	0
K101423	OPTIBOND XTR	Kerr Corporation	2010-07-30	71	0
K100347	OPTIBOND SE	Kerr Corporation	2010-04-30	77	0
K100083	ESTHETICA	Kerr Corporation	2010-03-19	66	0
K092176	TAKE 1 ADVANCED RIGID TRAY	Kerr Corporation	2010-01-28	191	0
K093484	PREMISE FLOWABLE MODIFIED	Kerr Corporation	2010-01-27	79	0
K091023	METAMORPHOSIS	Kerr Corporation	2009-05-21	41	0
K073209	MAXCEM 2	Kerr Corporation	2008-01-29	76	3
K071429	TI2200 TRANSILLUMINATION CABLE	Kerr Corporation	2007-09-10	110	0
K071251	DEMI	Kerr Corporation	2007-07-26	83	0
K062519	NEXUS 3	Kerr Corporation	2006-10-19	52	0
K060472	PREMISE FLOWABLE	Kerr Corporation	2006-04-28	64	42

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