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510(k) Data Aggregation

    K Number
    K131760
    Device Name
    WHIP MIX PREPPIES PLUS
    Manufacturer
    WHIP-MIX CORP.
    Date Cleared
    2014-03-26

    (282 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHIP-MIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to; - . Restoration cementation. - Acid etching procedures: . - o Sealants - Orthodontic brackets o - 0 Composite restorations
    Device Description
    Whip Mix Preppies Plus is an innovative blend of polishing and cleaning agents including 2% Chlorhexidine Gluconate (CHG) relative to liquid component and is in a paste form. Each cup provides enough flour of pumice paste for a single use. Preppies Plus has no fluoride, oils, or added flavoring agents.
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    K Number
    K092857
    Device Name
    VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS
    Manufacturer
    WHIP-MIX CORP.
    Date Cleared
    2010-03-04

    (169 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHIP-MIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The abutment is placed over the implant and is mounted on to the implant with an abutment screw. This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Hexed, 3i, 3i Certain, Zimmer, Endopore, Nobel Replace, Southern Trilobe, Astra and Straumann. This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Angled abutments and narrow diameter implants are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
    Device Description
    The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration. Vericore Abutments are made from Titanium grade Ti-6Al-4V. The abutment screws and are made from Titanium grade Ti-6A1-4V. The abutment is made to be placed over the implant and is mounted on to the implant with an abutment screw. The abutments are compatible with the following implant systems: Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i - Regular Hexed 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore -- Narrow, Regular and 5mm Nobel Replace- Narrow, Regular, Wide and 6mm Southern Trilock - Narrow, Regular and Wide Astra - Narrow and Regular Straumann - Narrow, Regular and Wide
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    K Number
    K090976
    Device Name
    VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS
    Manufacturer
    WHIP-MIX CORP.
    Date Cleared
    2009-06-25

    (80 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHIP-MIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The abutment is placed over the implant and is mounted on to the implant with an abutment screw. This device is compatible with the following manufacturers' implant systems: Branemark, Southern Hexed, 3i, 3i Certain, Zimmer and Endopore. This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also highly angled abutments (i.e. 15 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant. Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide
    Device Description
    The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration. Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws are made from Titanium grade Ti-6A1-4V The abutment is placed over the implant and is mounted on to the implant with an abutment screw The abutments are compatible with the following implant systems: Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i -Micro Mini, Regular Hexed, 5mm 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore - Narrow, Regular and 5mm Astra - Narrow and Regular Straumann - Narrow, Regular, Wide
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    K Number
    K082299
    Device Name
    VERICORE IMPLANT ABUTMENTS
    Manufacturer
    WHIP-MIX CORP.
    Date Cleared
    2008-11-20

    (100 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    WHIP-MIX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. In is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implan that can not be milled into the abutment. This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Trilock. This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Also highly angled abutments (i.e. 28 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended foor the posterior region due to limited strength of the implant. Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Narrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)
    Device Description
    The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration. Vericore Abutments are made from biocompatible yttria-stablized zirconia blocks. The abutment screws and adaptors are made from Titanium grade Ti-6A1-4V for the screws and Grade 4 for the adaptors. The abutment is placed over the implant and is mounted on to the implant with an abutment screw; an abutment adaptor will be added between the implant and the abutment. The abutment adaptor is intended to interface between the abutment and the implant allowing the abutment to meet with and be sealed to the parts of the implant that can not be milled into the abutment. The abutments are compatible with the following implant systems: Replace- Narrow (3.5mm), Regular (4.3mm), Wide (5.0mm) and 6mm Southern Trilock - Natrow (3.5mm), Regular (4.3mm) and Wide (5.0mm)
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