Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

EKZ — Predicate Candidate Screening

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

98 daysmedian FDA review time

278 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K213477	Root ZX3	J. Morita USA, Inc.	2022-08-03	278	0
K071632	PERFECT TISSUE CONTOURING SYSTEM II	Coltene/Whaledent, Inc.	2007-10-18	126	0
K063468	THE FUGO BLADE FOR DENTISTRY	Medisurg , Ltd.	2007-04-18	153	0
K052622	MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT	Macan Engineering Co.	2005-12-09	77	1
K050735	MC6A	Macan Engineering Co.	2005-05-23	63	0
K023672	X O ODONTOSURGE 4	Xo Care A/S	2003-04-29	179	0
K020080	BONART ART-E1 ELECTROSURGERY UNIT	Diagnostic Data, Inc.	2002-02-19	41	0
K001560	ODONTOSURGE 3	Odonto-Wave	2000-08-24	97	0
K000768	WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR	Wallach Surgical Devices, Inc.	2000-04-11	33	0
K982229	BI-DENT	Valley Forge Scientific Corp.	1998-08-13	90	0
K981390	ODONTOSURGE 2	Periogiene	1998-06-11	56	0
K962445	ARTHROCARE DENTAL ELECTROSURGERY SYSTEM	Arthrocare Corp.	1996-07-30	36	0
K955176	DENTO-SURGE	Ellman Intl., Inc.	1996-04-15	154	0
K950239	SENSIMATIC 500SE	Parkell, Inc.	1995-06-06	137	0
K925116	ELECTROSURGICAL ELECTRODE	Premier	1994-03-01	508	0
K921604	TOUCH N' HEAT, MODIFICATION	Analytic Technology	1992-08-24	150	0
K852522	SATALEC SERVOTOME	Spelna, Inc.	1985-12-27	196	0
K850666	STROBEX ULTRON ELECTROSURGE-DENTAL UNIT	Ipco Corp.	1985-05-29	98	0
K830441	DIFF 4 SYSTEM	Coulter Electronics, Inc.	1983-05-16	95	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