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510(k) Data Aggregation

    K Number
    K161177
    Device Name
    Axiom PX
    Manufacturer
    ANTHOGYR SAS
    Date Cleared
    2017-06-15

    (415 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANTHOGYR SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Anthogyr dental implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. Anthogyr dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.
    Device Description
    The AXIOM® PX implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The file concerns the implants and abutment screws. The prosthetic components and surgical instrumentation are the same as for the AXIOM® REG (see 510(k) K101913 and K131066) and are compatible with Axiom® PX implants. Implants: Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw. Material: Ti6AI4V-ELI Surface treatment: BCP® Dimensions, Ø3.4, length 8, 10, 12, 14, 16, 18 mm Ø 4.0, length 8, 10, 12, 14, 16, 18 mm Ø4.6, length 6.5, 8, 10, 12, 14 mm Ø5.2, length 6.5, 8, 10, 12 mm Screws: Screwing the abutment into the implant and the secondary parts into the abutment. Material: Ti6AI4V-ELI Surface treatment: DLC Dimensions: M1.4, length 5, 7.9 mm
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    K Number
    K141450
    Device Name
    AXIOM 2.8
    Manufacturer
    ANTHOGYR SAS
    Date Cleared
    2014-09-17

    (107 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANTHOGYR SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANTHOGYR implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for fixation of single tooth restorations. ANTHOGYR dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading. Axiom® 2.8 implants are indicated for single replacement of mandibular incisors and lateral maxillary incisors in cases presenting a restricted mesiodistal space. The prosthetic components of the Axiom 2.8 product line are intended to ensure support for single crowns only.
    Device Description
    The AXIOM® 2.8 implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The implant-abutment combination can support occlusal charge without risk of damaging the restoration and will not generate hazardous peek of stress at the prosthetic interface level. The file concerns the implants and abutments. Implants: Replacement of a missing root for placement of a dental restoration. Material: Ti6Al4V Surface treatment: BCP® Dimensions: Ø2.8, length: 10-14 mm Abutments: Provide support for a single permanent restoration. Material: Ti6Al4V Dimensions: Ø2.8 Angle: 0-23° Gingival height: 1-5.5 mm Temporary abutments: Provide support for a temporary restoration. Material: PEEK Dimensions:Ø2.8 Gingival height: 1-5.5 mm
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    K Number
    K131066
    Device Name
    AXIOM REG
    Manufacturer
    ANTHOGYR SAS
    Date Cleared
    2014-02-21

    (311 days)

    Product Code
    DZE, NHA
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANTHOGYR SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Anthogyr AXIOM® REG implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. The Axiom dental system is indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading. Prefabricated components are intended for use as accessories to dental implants to support implant-supported restorations.
    Device Description
    The AXIOM® REG Implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The file concerns the expansion of prosthetic components and surgical instrumentation and also the implants of the AXIOM® REG. Any abutment can be assembled on any AXIOM® REG implant thanks to its unique prosthetic connection, regardless of the implant diameter chosen. - Implants Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw. Material: Ti6Al4V Surface treatment: BCP® Dimensions: Ø3.4 mm, length: 16-18 mm Ø 4.0 mm, length: 16-18 mm - Conical abutments Provide support for a permanent restoration, for multiple screw-retained prosthesis and screw-retained bar and brace Material: Ti6Al4V Dimensions: gingival height: 4.5 mm angle: 18-30° Rotational and non rotational abutments. - Aesthetic titanium abutments Provide support for a permanent restoration, single and multiple-unit cemented restoration. Material: Ti6Al4V Dimensions: Ø3.4 mm; gingival height: 2.5-4.5 mm; angle: 7-15° Ø4.0 mm; gingival height: 0.75-4.5 mm; angle: 0-23° Ø5.0 mm; gingival height: 0.75-4.5 mm; angle: 0-23° Ø6.0 mm; gingival height: 1.5-4.5 mm; angle: 0-15° Standard angulated titanium abutments Provide support for a permanent restoration Material: Ti6Al4V Dimensions: Ø4.0 mm; gingival height: 1.5-3.5 mm; angle 15-23° Ø5.0 mm; gingival height: 1.5-3.5 m; angle 15-23° Temporary abutments Provide support for a temporary restoration Material: Ti6Al4V Dimensions: Ø3.4 mm; height: 1.5-4.5 mm Ø4.0 mm; height: 0.75-4.5 mm Ø5.0 mm; height: 0.75-4.5 mm Ø6.0 mm; height: 1.5-4.5 mm Healing screws and healing screws flat Sealing of implant conical connection during bone healing. Prepare gingiva to the permanent restoration shape. Material: Ti6Al4V Dimensions: Ø3.4 mm; height: 4.5 mm Ø4.0 mm; height: 0.75-4.5 mm Ø5.0 mm; height: 0.75-4.5 mm Ø6.0 mm; height: 4.5 mm Dimensions (flat version): Ø3.4 mm; height: 1.5-4.5 mm Ø4.0 mm; height: 0.75-4.5 mm Ø5.0 mm; height: 0.75-4.5 mm Ø6.0 mm; height: 1.5-4.5 mm Pacific system Ensure passive fit between the conical abutment and the framework. Reserved exclusively for multiple or full-arch screw-retained prostheses on straight conical abutments. Materials: Ti6Al4V, PMMA Temporary cap and protecting cap Give the negative shape of the permanent abutment for the design and realization by casting (lost wax process) of a dental restoration
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    K Number
    K111532
    Device Name
    MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
    Manufacturer
    ANTHOGYR SAS
    Date Cleared
    2011-10-07

    (126 days)

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

    ANTHOGYR SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications are very widespread in the field of implantology and surgery. The mentioned handpieces have been developed especially for the following applications : - MontBlanc Surgical contra-angle handpiece : for e.g. hemisection, wisdom tooth extraction. - MontBlanc Surgical straight handpiece : for e.g. application in the area of the front teeth, root tip resection, bone removal, osteotomy on the upper and lower jaw, preprosthetic surgical osteoplasty, sequestrum removal, fenestration on the alveolar appendix, apical ventilation, bone osteoplasty, bone smoothing.
    Device Description
    The device consists of MontBlanc Surgical contra-angle handpieces and straight handpieces with different reduction/multiplication rates, color codes, weights, light options (NO, OPTIC FIBER, LED), motor connection standards (ISO 3964, ISO 3964 (type Intra-Matic Lux), ISO 3964 (type Intra-Matic Lux with anthogyr connexion system)), maximum motor speed, tool types according to NF EN ISO 1797-1, diameter of tools according to NF EN ISO 1797-1, maximum length recommended by Anthogyr, maximum diameter of the active part of the tool recommended by Anthogyr, and water spray output according to ISO 7785-2.
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    K Number
    K102241
    Device Name
    ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
    Manufacturer
    ANTHOGYR SAS
    Date Cleared
    2011-03-23

    (226 days)

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

    ANTHOGYR SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANTHOGYR's IMPLANTEO implantology and dental surgery motor unit are indicated to perform dental implant surgery, such as perforating the bone and tapping and threading procedures required before placement of implant prosthetics.
    Device Description
    ANTHOGYR has developed "IMPLANTEO" implantology and dental surgery motor unit intended to perform dental implant surgery which is substantially equivalent to legally marketed and FDA cleared predicate devices. The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit consist of design improvement of non essential characteristics of the device. The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit has the same fundamental scientific technology, operating principle and intended use as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR implantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angle (K970953) or W&H implantMED (K052741) with contra-angle (K080939).
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    K Number
    K101913
    Device Name
    ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM
    Manufacturer
    ANTHOGYR SAS
    Date Cleared
    2011-03-11

    (246 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANTHOGYR SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANTHOGYR Dental Implant System implant AXIOM is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
    Device Description
    AXIOM dental implant system is designed to enhance the functional and aesthetic integration of implant supported restorations. AXIOM implants are made of grade V titanium and present a single connection (2.7 mm) common to all implant forms in the range. AXIOM implants are available in 4 diameters (3.4, 4.0, 4.6 and 5.2 mm) and various heights from 8 to 14 mm. AXIOM dental implant system includes all required prosthetic components and surgical instrumentation.
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