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

Heraeus Kulzer, Inc. — Predicate Candidate Screening

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

75 daysmedian FDA review time

156 days90th percentile

145clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K091494	FLEXITIME FLOW	Heraeus Kulzer, Inc.	2009-07-31	72	0
K063062	HKBOND 2006	Heraeus Kulzer, Inc.	2006-12-01	57	0
K060994	MONDIAL	Heraeus Kulzer, Inc.	2006-05-22	41	0
K052543	HERACERAM ZIRKONIA	Heraeus Kulzer, Inc.	2005-10-25	40	0
K043504	PALAIMPACT	Heraeus Kulzer, Inc.	2005-01-28	39	0
K043295	VERSYO.DIRECT	Heraeus Kulzer, Inc.	2005-01-05	37	0
K042878	FLEXITIME XTREME	Heraeus Kulzer, Inc.	2004-12-17	60	0
K030052	OSTIM	Heraeus Kulzer, Inc.	2004-12-06	700	0
K040859	HERACERAM PRESS	Heraeus Kulzer, Inc.	2004-05-20	48	0
K040043	NDX-40 ALLOY	Heraeus Kulzer, Inc.	2004-03-03	51	0
K033628	ARTIC	Heraeus Kulzer, Inc.	2004-01-16	58	0
K033665	VENUS FLOW	Heraeus Kulzer, Inc.	2003-12-30	39	0
K033629	VERSYO.BOND	Heraeus Kulzer, Inc.	2003-12-22	33	0
K030318	P2 POLYETHER	Heraeus Kulzer, Inc.	2003-04-03	63	4
K022612	IBOND GLUMA INSIDE	Heraeus Kulzer, Inc.	2002-10-28	83	0
K020131	VENUS UNIVERSAL LIGHT CURING COMPOSITE	Heraeus Kulzer, Inc.	2002-02-28	44	0
K012341	TRANSLUX ENERGY	Heraeus Kulzer, Inc.	2001-08-30	37	0
K010541	PREVISION CHEM	Heraeus Kulzer, Inc.	2001-07-31	158	0
K011130	PREMIUM	Heraeus Kulzer, Inc.	2001-07-05	83	0
K010800	VERSYO.COM	Heraeus Kulzer, Inc.	2001-05-31	76	0
K011036	RD-3008	Heraeus Kulzer, Inc.	2001-05-10	35	0
K003930	FLEXTIME MAGNUM 360	Heraeus Kulzer, Inc.	2001-02-01	43	0
K000629	FLEXTIME	Heraeus Kulzer, Inc.	2000-04-05	41	0
K993932	SOLITAIRE 2	Heraeus Kulzer, Inc.	1999-12-22	34	0
K993602	PRE-VISION FILL	Heraeus Kulzer, Inc.	1999-12-15	51	0
K992985	GLUMA COMFORT BOND	Heraeus Kulzer, Inc.	1999-10-14	41	0
K992292	GLUMA COMFORT BOND + DESENSITIZER	Heraeus Kulzer, Inc.	1999-10-01	86	2
K991425	XANTOPREN COMFORT	Heraeus Kulzer, Inc.	1999-06-15	53	0
K990756	FLOW LINE	Heraeus Kulzer, Inc.	1999-05-07	60	0
K990143	GLUMA ONE BOND	Heraeus Kulzer, Inc.	1999-02-25	37	0
K981546	NTI CLENCHING SUPPRESSION SYSTEM	Heraeus Kulzer, Inc.	1998-07-15	76	0
K974390	GLUMA ONE BOND	Heraeus Kulzer, Inc.	1998-02-04	75	0
K973694	PROVIL NOVO	Heraeus Kulzer, Inc.	1997-11-24	59	0
K971733	2 BOND 2	Heraeus Kulzer, Inc.	1997-10-02	146	0
K972101	SOLITAIRE	Heraeus Kulzer, Inc.	1997-09-29	117	29
K971155	MEMOREG	Heraeus Kulzer, Inc.	1997-05-22	55	0
K970848	SILOC SYSTEM	Heraeus Kulzer, Inc.	1997-05-06	60	0
K964038	CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG	Heraeus Kulzer, Inc.	1997-04-02	180	0
K965163	CUTTERSIL COMFORT	Heraeus Kulzer, Inc.	1997-03-19	85	0
K965165	CUTTERSIL COMFORT HARDENER	Heraeus Kulzer, Inc.	1997-03-19	85	0
K964140	GLUMA CONDITIONER	Heraeus Kulzer, Inc.	1996-11-05	21	0
K962812	GLUMA DESENSITIZER/GLUMA 3 PRIMER	Heraeus Kulzer, Inc.	1996-10-07	81	0
K961995	QUICKSPLINT	Heraeus Kulzer, Inc.	1996-06-26	36	0
K954929	CHARISMA SINGLE DOSE	Heraeus Kulzer, Inc.	1995-11-27	33	0
K953743	PALASPLINT	Heraeus Kulzer, Inc.	1995-10-02	54	0
K954115	ARTGLASS & KEVLOC	Heraeus Kulzer, Inc.	1995-09-27	58	0
K951058	GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION	Heraeus Kulzer, Inc.	1995-06-01	86	0
K951361	DCA 2000 SYSTEM FOR HEMOGLOBIN A1C	Heraeus Kulzer, Inc.	1995-05-05	39	1
K946183	CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER	Heraeus Kulzer, Inc.	1995-02-22	64	0
K943780	NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK	Heraeus Kulzer, Inc.	1994-10-31	89	7

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