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

J. Morita USA, Inc. · Predicate Candidate Screening

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

100 daysmedian FDA review time

278 days90th percentile

52clearances measured

K-number	Device	Applicant	Decided	Review days
K213477	Root ZX3	J. Morita USA, Inc.	2022-08-03	278
K201378	3D Accuitomo 150N	J. Morita USA, Inc.	2021-02-18	268
K190509	Lubrina 2	J. Morita USA, Inc.	2020-03-04	369
K173920	LS OIL	J. Morita USA, Inc.	2018-10-11	293
K171012	Veraview X800	J. Morita USA, Inc.	2017-12-19	259
K170275	Tri Auto ZX2	J. Morita USA, Inc.	2017-09-11	224
K120377	ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A	J. Morita USA, Inc.	2012-07-25	170
K112665	TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE	J. Morita USA, Inc.	2012-05-04	234
K103697	TORQTECH	J. Morita USA, Inc.	2012-01-20	396
K090925	MULTIPLE (APEX LOCATOR), MODEL RCM-7	J. Morita USA, Inc.	2009-11-23	235
K091065	AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4	J. Morita USA, Inc.	2009-10-16	185
K073695	3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17	J. Morita USA, Inc.	2008-04-09	100
K073696	VERAVIEWEPOCS	J. Morita USA, Inc.	2008-04-08	99
K073704	I-DIXEL	J. Morita USA, Inc.	2008-02-21	52
K071190	ROOT ZX II	J. Morita USA, Inc.	2007-08-17	109
K070074	LUBRINA, MODEL HIM-1	J. Morita USA, Inc.	2007-05-31	143
K063529	PENCURE, MODEL VL-7	J. Morita USA, Inc.	2007-01-05	44
K061664	FORMCORE DC, MODEL 28-700100	J. Morita USA, Inc.	2006-09-08	86
K060882	EXCEL BOND DC, MODEL 28-200100	J. Morita USA, Inc.	2006-09-01	154
K061701	HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN	J. Morita USA, Inc.	2006-08-25	70
K060844	SILKLINE SOFT RELINING KIT, MODEL 28-100100	J. Morita USA, Inc.	2006-06-06	70
K061322	PORCELAIN PRIMER	J. Morita USA, Inc.	2006-06-02	22
K053220	VERAVIEW IC 5, MODEL XDP1	J. Morita USA, Inc.	2006-01-06	50
K052587	3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF	J. Morita USA, Inc.	2005-12-27	98
K053030	J. MORITA AZ ULTRASONIC SYSTEM	J. Morita USA, Inc.	2005-11-07	11
K051780	JETLITE 5000	J. Morita USA, Inc.	2005-07-28	27
K043497	AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS	J. Morita USA, Inc.	2005-03-21	94
K043496	SPACELINE EMCIA, MODEL CU580	J. Morita USA, Inc.	2005-02-16	61
K043498	TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE	J. Morita USA, Inc.	2005-02-16	61
K042056	AZ ULTRASONIC SYSTEM	J. Morita USA, Inc.	2004-09-30	62
K031204	DENTAPORT ZX	J. Morita USA, Inc.	2003-08-21	127
K030450	3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH	J. Morita USA, Inc.	2003-05-06	84
K022147	DENTA PORT	J. Morita USA, Inc.	2002-12-20	171
K021372	VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABI	J. Morita USA, Inc.	2002-06-07	38
K012496	CARBON POST	J. Morita USA, Inc.	2002-05-17	287
K012849	GLASS POST	J. Morita USA, Inc.	2002-03-27	236
K020158	NON-EUGENOL TEMPORARY CEMENT	J. Morita USA, Inc.	2002-03-07	49
K020157	TEMPORARY CROWN AND BRIDGE MATERIAL	J. Morita USA, Inc.	2002-03-04	46
K013955	VERAVIEWEPOCS, MODEL VE	J. Morita USA, Inc.	2002-02-04	66
K002640	FREEDOM AUTOMATIC FILM PROCESSOR	J. Morita USA, Inc.	2000-11-08	76
K000078	JETLITE 4000	J. Morita USA, Inc.	2000-05-15	125
K992648	ROTARY MASTER	J. Morita USA, Inc.	2000-01-31	178
K992649	ATD AUTOMATIC BRIDGE REMOVER	J. Morita USA, Inc.	1999-10-29	84
K974077	VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.	J. Morita USA, Inc.	1998-01-20	83
K970339	TRI AUTO ZX	J. Morita USA, Inc.	1997-06-04	126
K964692	PERFECTIM	J. Morita USA, Inc.	1997-02-25	95
K963110	JETLITE	J. Morita USA, Inc.	1996-10-24	73
K953865	SPACELINE FEEL 21	J. Morita USA, Inc.	1996-03-20	216
K953867	ROOT CANAL LENGTH MEASURING DEVICE	J. Morita USA, Inc.	1995-12-01	106
K921979	ROOT ZX	J. Morita USA, Inc.	1993-05-27	394

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