BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    J. MORITA MFG. CORP.

    Reg #: 3002807636 · FEI: 3002807636 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    38
    Establishment Types
    3
    Classifications
    15

    Registration Details

    Registration Name
    J. MORITA MFG. CORP.
    Registration Number
    3002807636
    FEI Number
    3002807636
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    680 HIGASHIHAMA MINAMI-CHO,
    City
    FUSHIMI-KU Kyoto
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K061701

    Owner / Operator

    Firm Name
    J. MORITA MFG. CORP.
    Operator Number
    9048647
    Address
    680 HIGASHIHAMA MINAMI-CHO,, FUSHIMI-KU
    City
    KYOTO
    State
    JP-NOTA
    Postal Code
    612-8533
    Country
    JP

    US Agent

    Business Name
    FISH & RICHARDSON P.C.
    Contact Name
    KEITH Barritt
    Address
    1000 Maine Ave., S.W., Suite 1000
    City
    WASHINGTON
    State
    DC
    ZIP
    20024
    Country
    US
    Email
    [email protected]
    Phone
    202 7835070

    Products

    Device Name Product Code
    Handpiece, Belt And/Or Gear Driven, Dental EFA
    Handpiece, Air-Powered, Dental EFB
    Powered Laser Surgical Instrument GEX
    System, X-Ray, Extraoral Source, Digital MUH
    Locator, Root Apex LQY
    Handpiece, Direct Drive, Ac-Powered EKX
    X-Ray, Tomography, Computed, Dental OAS
    System, X-Ray, Tomography, Computed JAK
    Unit, Operative Dental EIA
    Light, Operating, Dental EAZ
    Unit, Electrosurgical, And Accessories, Dental EKZ
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Mirror, Mouth EAX
    System, Image Processing, Radiological LLZ
    Activator, Ultraviolet, For Polymerization EBZ

    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 LS OIL BEACH MOUTH MIRROR EndoSync EndoSync Plus TRI AUTO MINI VERAVIEW IC 5 MODEL XDP1 EndoSync A.I. RCM-7 i-dixel LUBRICARE LUBRINA STERLING Handpiece Maintenance System Air Solfy Root ZX II

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)