Medical Device Manufacturer · US , Irvine , CA

J. Morita USA, Inc.

52 submissions · 52 cleared · Since 1988
52
Total
52
Cleared
0
Denied

J. Morita USA, Inc. — FDA 510(k) Submissions

J. Morita USA, Inc. has submitted 52 FDA 510(k) premarket notifications since 1988, of which 52 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Handpiece, Direct Drive, Ac-powered, Handpiece, Air-powered, Dental, Locator, Root Apex, Activator, Ultraviolet, For Polymerization, System, X-ray, Tomography, Computed . Use the specialty filter in the sidebar to narrow results.

52 devices
1–25 of 52
Root ZX3
K213477 · EKZ Unit, Electrosurgical,... · Dental
Aug 2022 278d
3D Accuitomo 150N
K201378 · OAS X-ray, Tomography,... · Radiology
Feb 2021 268d
Lubrina 2
K190509 · EFB Handpiece, Air-powered,... · Dental
Mar 2020 369d
LS OIL
K173920 · EKX Handpiece, Direct Drive,... · Dental
Oct 2018 293d
Veraview X800
K171012 · OAS X-ray, Tomography,... · Radiology
Dec 2017 259d
Tri Auto ZX2
K170275 · EKX Handpiece, Direct Drive,... · Dental
Sep 2017 224d
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
K120377 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2012 170d
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
K112665 · EKX Handpiece, Direct Drive,... · Dental
May 2012 234d
TORQTECH
K103697 · EGS Handpiece, Contra- And... · Dental
Jan 2012 396d
MULTIPLE (APEX LOCATOR), MODEL RCM-7
K090925 · LQY Locator, Root Apex · Dental
Nov 2009 235d
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · EFB Handpiece, Air-powered,... · Dental
Oct 2009 185d
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
K073695 · JAK System, X-ray,... · Radiology
Apr 2008 100d
VERAVIEWEPOCS
K073696 · MUH System, X-ray, Extraoral... · Radiology
Apr 2008 99d
I-DIXEL
K073704 · LLZ System, Image Processing,... · Radiology
Feb 2008 52d
ROOT ZX II
K071190 · EKX Handpiece, Direct Drive,... · Dental
Aug 2007 109d
LUBRINA, MODEL HIM-1
K070074 · EFB Handpiece, Air-powered,... · Dental
May 2007 143d
PENCURE, MODEL VL-7
K063529 · EBZ Activator, Ultraviolet,... · Dental
Jan 2007 44d
FORMCORE DC, MODEL 28-700100
K061664 · EBF Material, Tooth Shade, Resin · Dental
Sep 2006 86d
EXCEL BOND DC, MODEL 28-200100
K060882 · KLE Agent, Tooth Bonding, Resin · Dental
Sep 2006 154d
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)
K061701 · EFA Handpiece, Belt And/or... · Dental
Aug 2006 70d
SILKLINE SOFT RELINING KIT, MODEL 28-100100
K060844 · EBI Resin, Denture, Relining,... · Dental
Jun 2006 70d
PORCELAIN PRIMER
K061322 · KLE Agent, Tooth Bonding, Resin · Dental
Jun 2006 22d
VERAVIEW IC 5, MODEL XDP1
K053220 · MUH System, X-ray, Extraoral... · Radiology
Jan 2006 50d
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF
K052587 · JAK System, X-ray,... · Radiology
Dec 2005 98d
J. MORITA AZ ULTRASONIC SYSTEM
K053030 · ELC Scaler, Ultrasonic · Dental
Nov 2005 11d
Filters