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

Kerr Dental Materials Center — Predicate Candidate Screening

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

63 daysmedian FDA review time

84 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K050984	BIOPLANT	Kerr Dental Materials Center	2005-08-11	114	0
K031444	OPTIBOND FL	Kerr Dental Materials Center	2003-07-02	56	0
K030646	BELLEGLASS POINT 4	Kerr Dental Materials Center	2003-05-06	67	0
K020303	XR PRIMER 2	Kerr Dental Materials Center	2002-04-19	80	0
K020178	BELLEGLASS HP MODELING GEL	Kerr Dental Materials Center	2002-03-15	56	0
K020092	TEMPHASE	Kerr Dental Materials Center	2002-02-22	43	0
K014027	OPTIBOND SOLO PLUS 4	Kerr Dental Materials Center	2002-02-22	78	1
K013375	BELLEGLASS HP OPAQUE 2	Kerr Dental Materials Center	2001-10-29	18	0
K013325	POINT 4 FLOWABLE 2	Kerr Dental Materials Center	2001-10-23	18	0
K011908	OPTIBOND SOLO PLUS 3	Kerr Dental Materials Center	2001-09-06	79	0
K000357	EZ CONNECT RESIN	Kerr Dental Materials Center	2000-04-28	84	0
K000346	EZ CONNECT	Kerr Dental Materials Center	2000-04-14	71	0
K992067	BELLEGLAZE	Kerr Dental Materials Center	1999-08-27	70	0
K983091	ELAN-2	Kerr Dental Materials Center	1998-10-28	55	0
K972844	TEMP BOND CLEAR	Kerr Dental Materials Center	1997-10-03	63	0
K962515	KERR ADVANCED ADHESIVE	Kerr Dental Materials Center	1996-08-01	35	0
K955337	OPAKER	Kerr Dental Materials Center	1996-01-23	63	0

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