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

EJT — Predicate Candidate Screening

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

41 daysmedian FDA review time

97 days90th percentile

627clearances measured

K-number	Device	Applicant	Decided	Review days
K052463	PROMETAL HN86	Prometal Technologies	2005-10-14	36
K041378	BIO 60	Kodent, Inc.	2004-08-02	70
K040672	PORTA REFLEX	Wieland Dental + Technik GmbH & Co. KG	2004-05-27	73
K040524	PORTA SOLDER 1090 W	Wieland Dental + Technik GmbH & Co. KG	2004-05-20	80
K040043	NDX-40 ALLOY	Heraeus Kulzer, Inc.	2004-03-03	51
K034049	HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HER	Heraeus Kulzer,GmbH	2004-03-01	62
K033279	GOLD DENTAL CASTING ALLOYS	Bego U.S.A.	2004-01-15	97
K033446	APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SA	We Dong Myung Dental Industrial Co., Ltd.	2003-11-13	15
K033435	E-SARANG 86, DM78, DM55	We Dong Myung Dental Industrial Co., Ltd.	2003-11-12	15
K032320	APPOLLO 3 ALLOY	Dentsply International	2003-10-01	65
K032317	ORION GX ALLOY	Dentsply Intl.	2003-09-30	64
K032319	CERA R PLUS ALLOY	Dentsply International	2003-09-30	64
K032318	MINERVA 58 ALLOY	Dentsply International	2003-09-30	64
K032321	CERA F ALLOY	Dentsply International	2003-09-30	64
K032316	ORION E ALLOY	Dentsply Intl.	2003-09-30	64
K032851	ULTRACROWN 75 ALLOY	Dentsply International	2003-09-26	14
K032715	DW 296 #15 SOLDER	Ivoclar Vivadent, Inc.	2003-09-26	24
K032267	R&D DESIGNATION AP-052-5	Jensen Industries, Inc.	2003-09-17	56
K032493	ALEXANDER	Ivoclar Vivadent, Inc.	2003-09-04	23
K032106	STARBOND DENTAL BONDING ALLOYS	Star Refining Precious Metals South Africa	2003-08-25	48
K031010	MIRACLE 98	Sb Lucius, Inc.	2003-06-25	86
K031264	PORTA PRESSOVER	Wieland Dental + Technik GmbH & Co. KG	2003-06-12	52
K031543	STARCAST DENTAL ALLOYS	Star Refining Precious Metals South Africa	2003-05-30	14
K030435	BIOUNIVERSAL PKF	Ivoclar Vivadent, Inc.	2003-04-15	64
K030436	BIO UNIVERSAL	Ivoclar Vivadent, Inc.	2003-04-15	64
K030312	PORTA IMPLANT	Wieland Dental + Technik GmbH & Co. KG	2003-03-26	55
K024136	AIGIS-SOFT	Sb Lucius, Inc.	2003-03-10	84
K024143	AIGIS-FINE	Sb Lucius, Inc.	2003-03-10	84
K024135	AIGIS-PLUS	Sb Lucius, Inc.	2003-03-10	84
K024142	AIGIS-SUPER	Sb Lucius, Inc.	2003-03-10	84
K024145	AIGIS-XO	Sb Lucius, Inc.	2003-03-07	81
K024139	AIGIS-INLAY	Sb Lucius, Inc.	2003-03-07	81
K024144	AIGIS-PT	Sb Lucius, Inc.	2003-03-07	81
K024141	NEO 76	Sb Lucius, Inc.	2003-03-06	80
K024140	AIGIS-A	Sb Lucius, Inc.	2003-03-06	80
K030206	APEX 90	We Dong Myung Dental Industrial Co., Ltd.	2003-01-29	8
K023831	UCP DENTAL MATERIAL	Precious Chemicals U.S.A., Inc.	2003-01-24	67
K023790	UCC DENTAL MATERIAL	Precious Chemicals U.S.A., Inc.	2003-01-21	69
K023501	GOLD CORE 35	Pentron Laboratory Technologies	2002-12-18	61
K023395	PORTADUR P2	Wieland Dental + Technik GmbH & Co. KG	2002-12-11	63
K023391	BIOPORTA G	Wieland Dental + Technik GmbH & Co. KG	2002-12-10	62
K023392	AGC SPECIAL ALLOY	Wieland Dental + Technik GmbH & Co. KG	2002-12-06	58
K023389	PORTA GEO TI	Wieland Dental + Technik GmbH & Co. KG	2002-12-06	58
K023197	CERANUM 82	Sb Lucius, Inc.	2002-11-05	41
K023200	CERANUM 76	Sb Lucius, Inc.	2002-11-04	40
K023199	CERANUM 50	Sb Lucius, Inc.	2002-11-04	40
K023196	LUCIUS 76	Sb Lucius, Inc.	2002-11-01	37
K023198	CERANUM 90	Sb Lucius, Inc.	2002-11-01	37
K022663	KERADEC	Wieland Dental + Technik GmbH & Co. KG	2002-10-31	83
K022969	UNIVERSAL CERAMIC SOLDER	Ivoclar Vivadent, Inc.	2002-10-18	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