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510(k) Data Aggregation

    K Number
    K192809
    Device Name
    Dental Handpiece
    Manufacturer
    Micro-NX Co., Ltd.
    Date Cleared
    2020-08-25

    (329 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
    Device Description
    Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth. In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures. Dental Handpiece is designed for use by a trained professional in the field of general dentistry. The proposed dental handpiece consists of the main body of a handpiece, which is used for transmitting a rotational force for the general dental treatments as well as accessory components. which are used for channeling water and air for further applications to the dental treatments. The torque transmitted from an electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear to be transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism. The product is offered as an electrical-powered Dental Handpiece that is reusable and ergonomically shaped. The dental handpiece can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the Dental Handpiece equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the proposed Dental Handpiece per ISO 1797:2017 (Dentistry - Shanks for rotary and oscillating instruments). Dental Handpiece has been developed with a full range of surgical contra angle intended to be used in implantology. The contra angle-design, size and performance of the proposed Dental Handpiece conform to ISO 14457 (2017) "Dentistry -Handpieces and motors" The six (6) product codes and models of Dental Handpiece are SG200L, SG200, CA100L, CA100R. SA100L. SA100R.The component names and functional descriptions for critical components of Dental Handpiece are provided in the table below.
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    K Number
    K163239
    Device Name
    SMARTmatic
    Manufacturer
    Kaltenbach & Voigt GmbH
    Date Cleared
    2017-03-17

    (119 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
    Device Description
    The SMARTmatic electrical-driven handpieces listed in the table below are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electricalpowered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the SMARTmatic handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the SMARTmatic handpieces per ISO 1797-1:2011 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals).
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    K Number
    K143465
    Device Name
    MASTERmatic LUX
    Manufacturer
    Kaltenbach & Voigt Gmbh
    Date Cleared
    2015-04-09

    (126 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MASTERmatic LUX handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
    Device Description
    The MASTERmatic LUX electrical-driven handpieces - MASTERmatic LUX M25 L, MASTERmatic LUX M20 L, MASTERmatic LUX M10 L, MASTERmatic LUX M07 L, MASTERmatic LUX M29 L, MASTERmatic LUX M05 L are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electrical-powered handpieces that are reusable and ergonomically shaped, and provided with a fiber optic light system. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the MASTERmatic LUX handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment through pouring holes and light for illumination the operation area. Dental burs and other attachments according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) will be used with the MASTERmatic LUX handpieces.
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    K Number
    K101172
    Device Name
    RDT3 HANDPIECE HEAD MODEL RDT3
    Manufacturer
    REDENT NOVA LTD
    Date Cleared
    2010-07-27

    (92 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).
    Device Description
    RDT3 is a reciprocating vertical vibrating handpiece attachment and is capable of providing the SAF with an impact movement of approximately 0.4 mm and up to 5,000 rpm drive speed required for conducting endodontic treatment. Low torque (max 9.5 ar cm) rotation motion is integrated in order to ease insertion of the file into the root canal. The file is attached to the RDT3 head via friction grip.
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    K Number
    K093894
    Device Name
    ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
    Manufacturer
    ANTHOGYR
    Date Cleared
    2010-03-03

    (75 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANTHOGYR's fully autoclavable contra-angles Implantology « Impulsion » are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.
    Device Description
    ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is « Impulsion » . ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces -Part 2: Straight and geared angle handpieces".
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    K Number
    K092446
    Device Name
    INTRA LUX HEAD 3 LDSY
    Manufacturer
    KALTENBACH & VOIGT GMBH & CO.
    Date Cleared
    2009-11-03

    (85 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is intended for use in root canal preparations using hand-held endodontic files.
    Device Description
    The INTRA Lux Head 3 LDSY reciprocating dental handpiece attachment is for use by a trained professional in general dentistry. The device is attached to air-powered or electrical handpieces. The reciprocating dental handpiece attachment is re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.
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    K Number
    K090055
    Device Name
    LOW & HIGH SPEED KIT
    Manufacturer
    DPM USA CORP.
    Date Cleared
    2009-10-27

    (292 days)

    Product Code
    EFA, EFB
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth. The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.
    Device Description
    The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth. The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.
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    K Number
    K092412
    Device Name
    STRONG IMPLANT HANDPIECES
    Manufacturer
    SAESHIN PRECISION CO., LTD.
    Date Cleared
    2009-09-03

    (28 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STRONG Implant Handpieces, ACL-411, ACL(B)-411, ACL-421, ACL(B)-421, ACL-431, ACL-(B)-431, ACL-451 and ACL(B)-451, are devices intended for a wide range of dental procedures including: - Endodontic surgeries, such as root canal preparations - Implant surgery such as perforating the bone, tapping and threading procedures - General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restorations and polishing teeth
    Device Description
    The STRONG Implant Handpieces; ACL-411. ACL(B)-41I. ACL-421. ACL(B)-421. ACL-431. ACL-(B)-431. ACL-451 and ACL(B)-451. are gear driven hand-held dental handpieces with transmission ratio of 20:1, 16:1, 32:1 and 64:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 counling. A Saline inigation system for surgery treatment is integral to the STRONG Implant Handpieces. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
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    K Number
    K090676
    Device Name
    MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
    Manufacturer
    ANTHOGYR
    Date Cleared
    2009-05-22

    (70 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" and ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restaurations and polishing teeth.
    Device Description
    ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 Dental Handpieces -Part 2: Straight and geared angle handpieces". ANTHOGYR has developed a full range of general dentistry contra angle intended to be used in general dentistry. The name of the range is "MontBlanc". ANTHOGYR Contra anales design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared anale handbieces".
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    K Number
    K070084
    Device Name
    MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
    Manufacturer
    EST. ANTHOGYR
    Date Cleared
    2007-03-08

    (58 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Why did this record match?
    Product Code :

    EFA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" Control are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.
    Device Description
    ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to N.F. EN ISO 7785-2 "Dental Handpieces -Part 2: Straight and geared angle handpieces: ".
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