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510(k) Data Aggregation

    K Number
    K132984
    Device Name
    SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2014-01-14

    (112 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
    Device Description
    Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
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    K Number
    K122955
    Device Name
    DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
    Manufacturer
    WRIGHT HEALTH GROUP LTD.
    Date Cleared
    2013-03-01

    (157 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymenzation process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.
    Device Description
    The synthetic plastic teeth are used in the production of dentures. They are produced from a I he synuletic process. Polymethylmethacrylate or PMMA is mixed with methylmethacrylate monomer, a cross linking agent and non-toxic pigments under heat and pressure. Once the monomer, a cross iniking agoit and non teen are checked for flash and polished according to the relevant model characteristics.
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    K Number
    K122925
    Device Name
    NEW STETIC ARTIFICIAL TEETH
    Manufacturer
    NEW STETIC
    Date Cleared
    2013-02-12

    (141 days)

    Product Code
    ELM, INT
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.
    Device Description
    The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.
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    K Number
    K122852
    Device Name
    PHYSIOSTAR NFC
    Manufacturer
    CANDULOR USA, INC.
    Date Cleared
    2012-12-06

    (79 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Physiostar NFC denture teeth are intended to be used for complete and partial denture r nyslostar NF & dontare tooling and implant-supported dentures.
    Device Description
    Not Found
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    K Number
    K121749
    Device Name
    VERACIA
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2012-09-07

    (85 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used as artificial teeth to produce partial and full dentures.
    Device Description
    Not Found
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    K Number
    K120404
    Device Name
    MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
    Manufacturer
    MERZ DENTAL GMBH
    Date Cleared
    2012-05-21

    (102 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Artegral HD are posterior preformed plastic denture teeth for use in: - supra construction for combined, fixed removable dental prostheses . - hybrid construction for implant-supported dental prostheses . - cover denture . - total prostheses . - model cast prostheses ● - . partial dentures
    Device Description
    artegral HD are preformed posterior plastic teeth made from an Interpenetrated Network (IPN) of polymethylmethacrylate (PMMA) with two finer Networks. The tooth neck is made from Organic Modified Polymer Network (OMP-N) and the incisal and dentine portions of the tooth are made from Highly Modified Polymer-Network (HMP-N). OMP-N has added insoluble PMMA spheres, and HMP-N has added amorphous silicon dioxide nanoparticles and fluorapatite. The artegral HD teeth comply with all the requirement of ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses. The additives in artegral HD teeth are known biocompatible materials.
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    K Number
    K120736
    Device Name
    SR PHONARES II
    Manufacturer
    IVOCLAR VIVADENT AG
    Date Cleared
    2012-05-14

    (66 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SR Phonares II denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.
    Device Description
    Not Found
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    K Number
    K113426
    Device Name
    VERACIA SA
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2012-02-08

    (82 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used as artificial teeth to produce partial and full dentures.
    Device Description
    Not Found
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    K Number
    K101064
    Device Name
    BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
    Manufacturer
    BREDENT GMBH & CO.KG
    Date Cleared
    2010-09-14

    (151 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novo:lign P are used for temporary or partial or full dentures. Permanent veneering: - telescopic and conical crowns - CoCr clasp restorations - crowns and bridges - implant-supported restorations - coverdenture techniques Veneer-up: - selection of esthetic shade, shape and tooth position Temporary restorations: - laboratory-made temporaries based on impression and wax-up - veneer on temporary abutments after placement of the implant The devices are offered in non-sterile condition.
    Device Description
    Bredent novo.lign A / novo.lign P artificial are multi-layer veneers for anterior and posterior teeth. Theses teeth devices are chemically based on polymethacrylate-polymers and their chemical properties. These reformed plastic dentures are used when fabricating any kind of dental restauration (see application range beneath).
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    K Number
    K101029
    Device Name
    KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
    Manufacturer
    HUGE DENTAL MATERIAL CO., LTD.
    Date Cleared
    2010-08-16

    (125 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Why did this record match?
    Product Code :

    ELM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for use as a tooth in a denture. These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
    Device Description
    The Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) used in the production of dentures are produced through a dough molding process. Polymethylmethacrylate (PMMA) is mixed with methylmethacrylate monomer and a crosslinking agent. Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them.
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