J. MORITA MFG. CORP.

FDA Device Registration & Listing · FUSHIMI-KU Kyoto, JP · Registration 3002807636

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002807636
FEI Number
3002807636
Entity Name
J. MORITA MFG. CORP.
City/State/Country
FUSHIMI-KU Kyoto, JP
Establishment Address
680 HIGASHIHAMA MINAMI-CHO,, FUSHIMI-KU Kyoto 612-8533, JP
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
J. MORITA MFG. CORP. (Owner Number: 9048647)
Owner / Operator Contact Address
680 HIGASHIHAMA MINAMI-CHO,, FUSHIMI-KU, KYOTO, JP-NOTA 612-8533, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K103697
PMA Number
N/A

All Registered Proprietary Names

STERLING XLR8 Plus ARETE Midwest 45 HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWINPOWER TURBINE 4H) AIR TORX ADVERL EVO ER: YAG LASER FOR DENTISTRY Veraviewepocs Model X550 Tri Auto ZX2 Veraview X800 3D Accu-I-tomo Model MCT-1EX-1F8/F17 MODEL CU580 SPACELINE EMCIA FEEL 21 DENTAL OPERATING LIGHT LUNA-VUE DENTAL OPERATING LIGHT Veraview FX800 Model X800N LUBRINA 2 Sterling Express Lubricare 2 ARETE Handpiece Maintenance Unit RZX3 ROOT ZX3 TORQTECH

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFA Handpiece, Belt And/Or Gear Driven, Dental Dental Class 1 872.4200 2006-09-06
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2009-10-24
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-07-30
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2008-04-09
LQY Locator, Root Apex Unknown Class U N/A 2017-09-19
EKX Handpiece, Direct Drive, Ac-Powered Dental Class 1 872.4200 2017-09-19
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2017-12-27
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2017-12-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2008-04-09
EIA Unit, Operative Dental Dental Class 1 872.6640 2006-03-09
EAZ Light, Operating, Dental Dental Class 1 872.4630 2004-04-08
MUH System, X-Ray, Extraoral Source, Digital Dental Class 2 872.1800 2021-02-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2021-02-23
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2021-02-23
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2020-03-10
EKZ Unit, Electrosurgical, And Accessories, Dental Dental Class 2 872.4920 2022-08-11
LQY Locator, Root Apex Unknown Class U N/A 2022-08-11
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2012-01-31

Official Correspondent

No official correspondent registered.

US Agent Details

KEITH Barritt Business: FISH & RICHARDSON P.C. Email: barritt@fr.com Phone: (202) 7835070

Related Public Records

Same Entity

J. MORITA MFG. CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010281549 J. MORITA MFG. CORP., TOTTORI FACTORY Kurayoshi Tottori, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807636. Last updated year: 2026. Please use registration number 3002807636 when referencing this establishment in official correspondence.
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