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

ELL — Predicate Candidate Screening

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

78 daysmedian FDA review time

216 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K240586	Additive Manufacturing Zirconia Customized Restoration	Hangzhou Thales Medtech Co., Ltd.	2024-10-03	216
K203072	Franz Zirconia Dental Crown	Franz Biotech, Inc.	2022-01-19	467
K162043	NobelProcera HT ML FCZ Bridge	Nobel Biocare AB	2016-11-22	120
K153534	NobelProcera HT ML Full Contour Zirconia Crown	Nobel Biocare AB	2016-06-06	180
K071182	PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO	Nobel Biocare AB	2007-07-11	72
K060530	SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301.	Lifecore Biomedical, Inc.	2006-05-22	83
K041283	PROCERA BRIDGE ZIRCONIA	Nobel Biocare AB	2004-05-28	15
K032562	PROCEARA COPINGS AND PONTIC	Nobel Biocare AB	2004-02-06	170
K965216	ARGI-SATIN OR OPTI0-STAR	Argen Precious Metals, Inc.	1997-02-27	59
K960770	MATCHMAKER/PROPAQUE PORCELAIN	Davis Schottlander & Davis, Ltd.	1996-11-19	267
K960480	IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013	Vident	1996-03-15	42
K930835	VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A	Ivoclar North America, Inc.	1994-07-22	520
K932012	CAPS	Chemichl, Inc.	1993-11-03	194
K931808	DUCERAGOLD, DUCERATIN	Degussa AG	1993-11-03	205
K924823	MICRODOSE SILANE	Unicep	1993-03-16	169
K924821	MICRODOSE PORCELAIN ETCHANT	Unicep	1993-03-16	169
K923926	IPS CERAMIC ETCHING GEL	Ivoclar North America, Inc.	1992-10-27	83
K920460	4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL	Pulpdent Corp.	1992-04-28	92
K910569	TYCERAMIC	Jeneric/Pentron, Inc.	1991-04-15	63
K910303	SYSNPAR PORCELAIN	Jeneric/Pentron, Inc.	1991-03-08	43
K903907	PROCERAM PORCELAIN	Nobelpharma USA, Inc.	1990-11-09	78
K895269	DEN-MAT LAMI-QUICK	Den-Mat Corp.	1990-02-22	183
K893481	CRYSTAR(TM) ANTI-GREENING LIQUID	Shofu Dental Corp.	1989-07-14	71
K892806	TUF-COAT	G-C Intl. Corp.	1989-07-14	88
K884214	CRYSTAR(TM) VINTAGE PORCELAIN	Shofu Dental Corp.	1988-12-08	63
K880774	SPECTRUM	Dentsply Intl.	1988-05-18	82
K880764	G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER	G-C Intl. Corp.	1988-04-12	46
K875351	DEN-MAT PORETCH (PORCELAIN ETCHANT)	Den-Mat Corp.	1988-03-18	78
K871808	DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM	Degussa Dental, Inc.	1987-06-05	28
K864724	MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN	Dentsply Intl.	1987-02-17	77
K860608	ARTIFICIAL TEETH, PORCELAIN, MODIFIED	Dentsply Intl.	1986-03-26	35
K851733	DENTAL PORCELAIN-VARIOUS	Excelco Intl., Inc.	1985-10-16	174
K852145	CAPA PRE-FORMED PORCELAIN CROWN	Capa Industries	1985-07-02	47
K841826	NATURA-DENT VACUUM-FIRED PORCELAIN TEETH	Parexel Intl. Corp.	1984-07-12	71
K840642	THERMOCRAFT PORCELAIN	American Thermocraft Corp.	1984-03-30	44
K823744	PORCELAIN ARTIFICIAL TEETH	Dentsply Intl.	1982-12-28	15
K800829	MYERSON R&KENSON R PORCELAIN ANT&POS.-	Myerson Tooth Corp.	1980-05-08	24
K781935	NU-GLAZE	Deringer-Ney, Inc.	1978-12-20	30
K771179	BIOBOND MASTER STAIN AND GLAZE KIT	Dentsply Intl.	1977-07-15	15

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