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510(k) Data Aggregation

    K Number
    K233153
    Device Name
    Traus SSG10 Surgical System
    Manufacturer
    Saeshin Precision Co., Ltd.
    Date Cleared
    2024-09-20

    (359 days)

    Product Code
    HBC, HBE
    Regulation Number
    882.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Saeshin Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Traus SSG10 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical procedures.
    Device Description
    Traus SSG10 Surgical System is composed of a control box, micro motor and a foot controller as an electric bone surgery machine. A signal for operating a foot controller, a handpiece, etc.., is transmitted when a power source is inputted to a control box (main body) to control functions such as rotational speed, torque and water injection amount. It is a mechanism for puncturing, and cutting bones and human tissues through rotation and reciprocating motion by connecting handpieces and attachments to a micro motor. Three modes (Drill, Saw, Shaver) can be set, and the handpiece and attachment for each mode can be used in many surgical areas.
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    K Number
    K232938
    Device Name
    Traus SSG30 Surgical System
    Manufacturer
    Saeshin Precision Co., Ltd.
    Date Cleared
    2024-09-16

    (362 days)

    Product Code
    HBC, CLA
    Regulation Number
    882.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Saeshin Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Traus SSG30 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical procedures.
    Device Description
    Traus SSG30 Surgical System, is available to apply surgical operation by various handpieces incorporating a micro motor and a handpiece. The technological characteristics and operating parameters of OSSEODUO Shaver and Drill System is very similar to the predicate device. With respect to the functional aspects, Traus SSG30 Surgical System, Bone surgery Engine Unit, uses the same fundamental technology as the predicate device. Traus SSG30 Surgical System consists of a control box (main unit), foot controller, micro motor and handpieces. Traus SSG30 Surgical System is composed of a control box, micro motor and a foot controller as an electric bone surgery machine. A signal for operating a foot controller, a handpiece, etc... is transmitted when a power source is inputted to a control box (main body) to control functions such as rotational speed, torque and water injection amount. It is a mechanism for puncturing, and cutting bones and human tissues through rotation and reciprocating motion by connecting handpiece and attachments to a micro motor. Three modes (Drill, Saw, Shaver) can be set, and the handpiece and attachment for each mode can be used in many surgical areas.
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    K Number
    K221741
    Device Name
    TRAUS Air Dental Handpiece
    Manufacturer
    Saeshin Precision Co., Ltd.
    Date Cleared
    2023-02-22

    (252 days)

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

    Saeshin Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This air-powered dental handpiece is intended for removal of carious material, cavities and crown preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.
    Device Description
    The TRAUS Air Dental handpieces are air driven dental handpieces for the use by a trained dental professional. The devices are air-powered handpieces that are reusable and designed accordance with international standard. The devices can be sterilized by the prevacuum steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high-speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port. Using in combination with dental unit chair, it is possible to use by installing the instrument at air handpiece according to purpose. It is possible to change the rotation speed by adjusting the flowing air.
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    K Number
    K212043
    Device Name
    TRAUS ENDO
    Manufacturer
    Saeshin Precision Co., Ltd.
    Date Cleared
    2022-06-24

    (359 days)

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

    Saeshin Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).
    Device Description
    The TRAUS ENDO is an AC-powered device that includes a power unit, charging station and contra-angle handpieces, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, which are used for grinding, cutting, and polishing work in dental oral use. It is used for endodontic surgery with 600-1,000 rpm.
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    K Number
    K201292
    Device Name
    TRAUS SIP20
    Manufacturer
    Saeshin Precision Co., Ltd.
    Date Cleared
    2021-02-11

    (273 days)

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

    Saeshin Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRAUS SIP20 is intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanial rotating root canal preparation.
    Device Description
    TRAUS SIP20 is an AC-powered device that includes a hand-held motor, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental surgery.
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    K Number
    K192561
    Device Name
    TRAUS SUS20
    Manufacturer
    Saeshin Precision Co., Ltd.
    Date Cleared
    2020-07-13

    (300 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Saeshin Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation.
    Device Description
    TRAUS SUS20 has the function of piezo surgery by using ultrasonic mechanical vibration. TRAUS SUS20 consists of a control box (main unit), a piezo handpiece and a foot controller.
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    K Number
    K182892
    Device Name
    TRAUS Dental Handpieces
    Manufacturer
    Saeshin Precision Co., Ltd.
    Date Cleared
    2019-11-26

    (407 days)

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

    Saeshin Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN are intended for a wide range of dental procedures including: A. Implant placement , including - 1. Preparation of the osteotomy site - 2. Bone contouring , osteoplasty - B. Periodontal surgeries - 1. Bone contouring & alveoplasty around living teeth - 2. Removal of exostosis - C. Bone grafting - 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.) - 2. Harvesting autogen living bone - 3. Sinus elevation & grafting of alveolar sockets D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions
    Device Description
    The TRAUS Dental Handpieces; TRAUS CRB46LN and TRAUS CRB46NN are gear driven hand-held dental handpieces with Gear Ratio of 20:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
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    K Number
    K181129
    Device Name
    STRONG Dental Handpieces
    Manufacturer
    Saeshin Precision Co., Ltd.
    Date Cleared
    2019-01-31

    (276 days)

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

    Saeshin Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Strong Dental Handpiece, ACL(B)-46EP is intended for wide range of dental procedures, including: A. Implant placement, including - 1. Preparation of the osteotomy site - 2. Bone contouring, osteoplasty - B. Periodontal surgeries - 1. Bone contouring & alveoplasty around living teeth - 2. Removal of exostosis - C. Bone grafting - 1.Preparation of the donor site (for e.g. symphysis and ascending rames etc.) - 2. Harvesting autogen living bone - 3. Sinus elevation & grafting of alveolar sockets D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions.
    Device Description
    Not Found
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    K Number
    K171436
    Device Name
    STRONG Dental Handpieces
    Manufacturer
    Saeshin Precision Co., Ltd.
    Date Cleared
    2018-01-05

    (234 days)

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

    Saeshin Precision Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-631, ACL(B)-651 and ACL(B)-04C are intended for a wide range of dental procedures including: - A. Implant placement, including - 1. Preparation of the osteotomy site - 2. Bone contouring, osteoplasty B. Periodontal surgeries - 1. Bone contouring & alveoplasty around living teeth 2. Removal of exostosis C. Bone grafting - 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.) - 2. Harvesting autogen living bone - 3. Sinus elevation & grafting of alveolar sockets D. Removal and sectioning of teeth bone for e.g. impacted third molars and complicated extractions
    Device Description
    The STRONG Dental Handpieces; ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are gear driven hand-held dental handpieces with Gear Ratio of 20:1, 16:1, 64:1, 32:1 and 1:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
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    K Number
    K151171
    Device Name
    TRAUS SUS10
    Manufacturer
    SAESHIN PRECISION CO., LTD.
    Date Cleared
    2015-09-01

    (123 days)

    Product Code
    DZI, EBW, EGS
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAESHIN PRECISION CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRAUS SUS10, Piezo Surgery and Implant Engine Unit, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation (for ultrasonic surgery), and implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation (for dental implant surgery).
    Device Description
    TRAUS SUS10, Piezo Surgery and Implant Engine Unit, combines the function of piezo surgery by using ultrasonic mechanical vibration and the function of dental implant motor surgery into one device. TRAUS SUS10 includes a control box (main unit), foot controller and dental handpieces. The dental handpieces of TRAUS SUS10 are supplied with two types: Piezo handpiece and Dental implant motor handpiece incorporating an implant motor and an angle handpiece. When the AC power is connected to the control box by the power cord, the control box has a program for ultrasonic surgery mode which be able to select options such as power (output intensity) and boost (vibration frequency), and for implant motor surgery mode which be able to select options such as speed, torque and gear ratio, and includes the memory function for input and output settings.
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