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

EJH — Predicate Candidate Screening

153 FDA 510(k) clearances under this product code; the 50 most recent screened below.

54 daysmedian FDA review time

137 days90th percentile

153clearances measured

K-number	Device	Applicant	Decided	Review days
K123929	BEGOPAL+	Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO	2013-03-14	84
K040180	CONTINUM V	Aalba Dent, Inc.	2004-03-04	37
K040179	CONTINUM	Aalba Dent, Inc.	2004-03-03	36
K033356	VERASOFT ES	Aalba Dent, Inc.	2003-12-30	101
K033045	DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST,	American Green Dent. Mfg, Inc.	2003-12-23	85
K032136	WIROBOND C	Bego U.S.A.	2003-09-04	55
K031627	NANO-TICROWN	Nano-Write Corp.	2003-06-11	15
K030632	PD CASTA-H	Mountain Medico, Inc.	2003-05-07	68
K030416	CERACAST-V	Mountain Medico, Inc.	2003-04-14	63
K030161	SUPERBOND	American Dent-All, Inc.	2003-03-17	60
K024214	KAVO EVEREST TITANBLANK	Kavo America	2003-03-12	82
K023499	GOLD CORE PLUS	Pentron Laboratory Technologies	2003-01-13	87
K023502	JEWEL CAST PLUS	Pentron Laboratory Technologies	2002-12-18	61
K023477	BIOLOY	Neirynck & Vogt NV	2002-12-13	58
K021971	CERALOY	Neirynck & Vogt NV	2002-08-01	45
K021969	CHROLOY	Neirynck & Vogt NV	2002-07-30	43
K021965	CHROLOY SOLDER	Neirynck & Vogt NV	2002-07-26	39
K021968	CERALOY SOLDER	Neirynck & Vogt NV	2002-07-26	39
K020253	4 ALL (DW286A)	Ivoclar Vivadent, Inc.	2002-04-17	83
K020898	D.SIGN 15 (DW286 B)	Ivoclar Vivadent, Inc.	2002-03-29	64
K020183	PISCES PLUS (DW286 C)	Ivoclar Vivadent, Inc.	2002-03-13	54
K020062	XERAFIT	Metalor Technologies USA	2002-02-14	37
K011706	FLEXICAST PRIME	American Dent-All, Inc.	2001-08-06	63
K011705	SUPREMCAST	American Dent-All, Inc.	2001-08-03	60
K010381	D.SIGN 30	Ivoclar North America, Inc.	2001-03-06	26
K010069	DURABOND NON-PRECIOUS CERAMIC ALLOY	Matech, Inc.	2001-02-15	38
K003387	AUROFILM NP	Metalor Dental USA Corp.	2001-01-09	70
K003509	FLEXICAST	American Dent-All, Inc.	2001-01-02	49
K003037	JEWEL CAST III	Jeneric/Pentron, Inc.	2000-12-05	67
K003039	GOLD CORE II	Jeneric/Pentron, Inc.	2000-12-05	67
K002302	SUPER 14	Dental Alloy Products, Inc.	2000-09-26	60
K002300	SUPER 6	Dental Alloy Products, Inc.	2000-09-26	60
K002299	SUPER 3	Dental Alloy Products, Inc.	2000-09-08	42
K002301	SUPER 12	Dental Alloy Products, Inc.	2000-09-08	42
K002298	SUPER 1	Dental Alloy Products, Inc.	2000-08-24	27
K001798	DC TITAN	Austenal, Inc.	2000-07-31	47
K001383	SUPREMCAST V	American Dent-All, Inc.	2000-07-05	64
K001269	DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC	Dentalmatic Technologies, Inc.	2000-06-21	62
K000981	CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLU	C-Mix	2000-06-13	78
K993572	CERADIUM V NON-PRECIOUS CERAMIC ALLOY	Matech, Inc.	1999-12-13	53
K992881	HI BOND NON-PRECIOUS CERAMIC ALLOY	Matech, Inc.	1999-11-19	85
K993344	P10 SPECIAL	North American Alloys, Inc.	1999-11-15	41
K992705	CERADIUM NON-PRECIOUS CERAMIC ALLOY	Matech, Inc.	1999-09-22	42
K990235	D-SIGN VI (R&D PROJECT DW266#9)	Ivoclar North America, Inc.	1999-03-01	35
K990182	D-SIGN V (R&D PROJECT DW267#17)	Ivoclar North America, Inc.	1999-03-01	40
K984164	JELBOND NP	Jelenko Co.	1998-12-29	39
K982094	VERABOND 2	Aalba Dent, Inc.	1998-07-22	37
K972971	NPG + 2	Aalba Dent, Inc.	1998-01-05	147
K973567	SOWELL COBALT-CHROME METAL ALLOY	C.K. International Trading	1997-12-11	83
K973569	SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY	C.K. International Trading	1997-12-11	83

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