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510(k) Data Aggregation

    K Number
    K213477
    Device Name
    Root ZX3
    Manufacturer
    J. Morita USA, Inc.
    Date Cleared
    2022-08-03

    (278 days)

    Product Code
    EKZ, LQY
    Regulation Number
    872.4920
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. Morita USA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Root ZX3 device is a dental device with an apex locating function and an optional electrosurgical function and is composed of the aforementioned corresponding modules. The apex locating function of Root ZX3 device is used for root canal measurement and working length determination. The electrosurgical function is used for the following dental procedures: gingival incision and excision, gingivoplasty, gingivectomy, hemostasis, pulpotomy as an adjunct to root canal therapy, and excision of intraoral lesions. It is also used for the ablation of pulp, dental filling material (e.g. gutta-percha) and tissue in/around root canals as an adjunct to root canal therapy, after determining the tip position of the active electrode by apex location.
    Device Description
    The Root ZX3 device (also referred to by its model number RZX3) is a battery-driven apex locator with an optional dental electrosurgical unit, used in the oral cavity during dental procedures. This device has two modules: the main module is an apex locator module and the other is an electrosurgical module (high frequency [HF] module). The apex locator module is the basic module to which dental electrosurgical functions can be added by connecting the HF module.
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    K Number
    K201378
    Device Name
    3D Accuitomo 150N
    Manufacturer
    J. Morita USA, INC.
    Date Cleared
    2021-02-18

    (268 days)

    Product Code
    OAS, JAK, MUH
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. Morita USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3D Accuitomo 150N Model X800N is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. The 3D Accuitomo 150N Model X800N is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the ENT, dentomaxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by medical doctors, dentists, and other legally qualified professionals for pediatric and adult patients.
    Device Description
    The X800N consists of the following components: x-ray arm with extraoral x-ray source assembly faced with x-ray detector, cephalometric support, high-voltage generator, control assembly, patient positioning device, and software containing communication and image construction. The X800N has three main radiographic modes as follows: - Panoramic tomography including linear tomography and scanogram - - Cephalometric radiography - - -Cone beam computed tomography
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    K Number
    K190509
    Device Name
    Lubrina 2
    Manufacturer
    J. Morita USA, Inc.
    Date Cleared
    2020-03-04

    (369 days)

    Product Code
    EFB, CLA
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. Morita USA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lubrina 2 is for lubricating and cleaning the inside of dental instruments.
    Device Description
    The Lubrina 2 device is used to maintain optimum performance and prolong the working life of dental handpieces. The Lubrina 2 delivers oil and air automatically to handpieces, and is used after dental treatment and before autoclaving. The Lubrina 2 is not installed in a dental operative unit, but rather is to be used on a table or shelf. There is only one model. The type varies depending on the country/area the device is to be shipped to and the power cord for that region is included in the package. For the USA, only model HIM-2 Type US, is to be marketed, together with the power cord for the USA. Operating Mechanism: The Lubrina 2 supplies lubrication oil to the inside of handpieces by automatically discharging pressurized air from spray can lubricant. Excess oil is removed from the handpiece by pressurized air. The Lubrina 2 has four operation modes: - Chuck Lubrication - Handpiece Body Lubrication - Flushing (Extended lubrication) - Air blow mode
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    K Number
    K173920
    Device Name
    LS OIL
    Manufacturer
    J. Morita USA, Inc.
    Date Cleared
    2018-10-11

    (293 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. Morita USA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LS OIL is a lubricant and is intended for use to lubricate dental handpieces.
    Device Description
    LS OIL is a lubricant intended for use with dental handpieces. It is comprised of the same paraffin oil and oiliness improver (fatty acid ester) as the previouslycleared LS SPRAY reference device. LS OIL is used after clinical use of dental handpieces before sterilization. It is directly added to the devices from its nozzle by dropping into inside of the handpieces. The LS OIL goes through the hollow of the devices and lubricates their components (gears, bearing, and rotating parts).
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    K Number
    K170275
    Device Name
    Tri Auto ZX2
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2017-09-11

    (224 days)

    Product Code
    EKX, LQY, REG, SEC
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. MORITA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tri Auto ZX2 device is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
    Device Description
    The Tri Auto ZX2 is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file and reamer. The Tri Auto ZX2 can be used for cutting and grinding teeth by transferring rotary movement to a rotary instrument attached to the head. Cutting and grinding of teeth can be done depending on the situation by switching (reversing) the rotation direction. Rotation speed is accelerated or decelerated according to the user's preference, rotation control based on torque detection, or set timing. These controls enable the cutting, grinding, enlargement, and preparation of root canals. Moreover, the Tri Auto ZX2 can be used for the removal of extraneous materials such as gutta-percha points, and for professional mechanical tooth cleaning. In addition, the Tri Auto ZX2 can be used as an apex locator, and the measured value can be used for rotation control. The Tri Auto ZX2 is intended to be sterilized prior to use.
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    K Number
    K120377
    Device Name
    ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2012-07-25

    (170 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. MORITA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device is intended for the incision, excision, vaporization, ablation and coagulation of soft tissue in oral and dentistry and for the ablation and vaporization of hard tissue in dentistry. Hard Tissue General Indications* · Class I, II, III, IV and V cavity preparation · Caries removal · Hard tissue surface roughening or etching · Enameloplasty, excavation of pits and fissures for placement of sealants * For use on adult and pediatric patients Root Canal Hard Tissue Indications · Tooth preparation to obtain access to root canal · Root canal preparation including enlargement · Root canal debridement and cleaning Bone Surgical Indications · Cutting, shaving, contouring and resection of oral osseous tissues (bone) · Osteotomy Endodontic Surgery (Root Amputation) Indications · Flap preparation - incision of soft tissue to prepare a flap and expose the bone. · Cutting bone to prepare a window access to the apex (apices) of the root(s). · Apicoectomy - amputation of the root end. · Root end preparation for retrofill amalgam or composite. · Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex. NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Laser Periodontal Procedures · Full thickness flap · Partial thickness flap · Split thickness flap · Laser soft tissue curettage · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium · Removal of granulation tissue from bony defects · Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) · Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) · Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) · Osseous crown lengthening · Removal of subgingival calculus Soft Tissue Indications including Pulpal Tissues* Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: · Excisional and incisional biopsies · Exposure of unerupted teeth · Fibroma removal · Flap preparation incision of soft tissue to prepare a flap and expose the bone. · Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) · Frenectomy and frenotomy · Gingival troughing for crown impressions · Gingivectomy · Gingivoplasty · Gingival incision and excision · Hemostasis and coagulation · Implant recovery · Incision and drainage of abscesses · Incision and drainage of periapical abscesses · Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery · Leukoplakia · Operculectomy · Oral papillectomies · Pulpotomy · Pulp extirpation · Pulpotomy as an adjunct to root canal therapy · Reduction of gingival hypertrophy · Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex . NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. · Root canal debridement and cleaning · Soft tissue crown lengthening · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa · Vestibuloplasty * For use on adult and pediatric patients
    Device Description
    Equipment is mobile Er: YAG Medical Treatment and Coagulation Laser of model MEY-1-A intended to be used for dental surgery in hospital environment. Er.YAG Laser emits an infrared beam with a wavelength 2.94 um which is readily absorbed by water contained by both hard and soft tissues of the human body. As a result, a energy of the laser beam instantly vaporized the water molecules in hard tissues of the tooth causing the tissues to crumble away or resection of the soft tissues of gingival.
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    K Number
    K112665
    Device Name
    TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2012-05-04

    (234 days)

    Product Code
    EKX
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. MORITA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tri Auto mini motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points, and for professional tooth cleaning. When connected to Apex locator, the Tri Auto mini can be used to measure the length of root canals.
    Device Description
    The Tri Auto mini is an battery-driven handpiece with a motor, equipped with the chuck for holding rotary instrument such as a dental file and a reamer. Tri Auto mini can be used for enlargement and preparation of root canals. When connected to Apex Locator (which is not included in this application), the Tri Auto mini indicates the position of the file tip inside the root canal.
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    K Number
    K103697
    Device Name
    TORQTECH
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2012-01-20

    (396 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. MORITA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TORQTECH transmits rotation of the motor to dental burrs and reamers which cut or grind teeth or dentures with the same or transformed rotation.
    Device Description
    The TORQTECH device is a dental handpiece to be attached to an electric or air powered dental motor, designed for polishing, grinding, and drilling of teeth/dentures. The device transmits rotational force from the motor to the rotor shaft through a clutch, and the dental burrs or reamers chucked on the shaft are able to polish, grind or cut the teeth/dentures of the patient receiving these rotations. There are two types of the TORQTECH device: one is a "straight" linear model (Model ST-DH) while the other is angled and geared (Models CA-DC, CA-DC-O, and CA-5IF-O). The geared models vary based on angle and rotation due to the gear between the clutch and rotor shaft. An optional headlight is available, fed through the light-guide from the motor portion.
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    K Number
    K090925
    Device Name
    MULTIPLE (APEX LOCATOR), MODEL RCM-7
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2009-11-23

    (235 days)

    Product Code
    LQY, LOY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. MORITA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
    Device Description
    The RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
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    K Number
    K091065
    Device Name
    AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
    Manufacturer
    J. MORITA USA, INC.
    Date Cleared
    2009-10-16

    (185 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    J. MORITA USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system. Attachments are geared handpieces that are used to drill and polish teeth.
    Device Description
    This instrument is designed for dental treatment such as grinding, drilling and polishing teeth.
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