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510(k) Data Aggregation

    K Number
    K190998
    Device Name
    BA Pit & Fissure Sealant
    Date Cleared
    2019-11-08

    (206 days)

    Product Code
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    Apex Dental Materials, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the biting surfaces of teeth. For dental professional use only.
    Device Description
    Pit and Fissure sealants are used as a preventive measure to fill defects and prevent decay within crevices, voids or fissures on the surface of teeth. These voids are more challenging to keep free of substances that can lead to caries and eventual breakdown of tooth structure. BA Pit & Fissure Sealant is a material designed to fill these voids with a wear resistant material, ultimately preserving natural tooth structure. BA Pit & Fissure Sealant is a light activated / photopolymerizable, glass filled, urethane dimethacrylate material that is placed onto an etched enamel surface and light activated for 20 seconds. The result after application is a tooth that has been sealed with a tough, wear resistant material.
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    K Number
    K161077
    Device Name
    RnD TE and RnD SE
    Date Cleared
    2017-03-17

    (333 days)

    Product Code
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Apex Dental Materials, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RnD TE and RnD SE is indicated for - · Desensitizing - · Rewetting - · Preventing Bond Degradation
    Device Description
    RnD TE and RnD SE is an aqueous primer used to rewet and desensitize a tooth prior to bonding. Bonding to tooth structure presents many challenges including the determination of the proper conditions for starting the bonding protocol. The tooth can be left too wet or too dry which could lead to debonding or post-operative sensitivity. RnD TE and R&D SE have been designed to aid in reaching the appropriate moisture level to provide an initial surface that allows an adhesive to reach its full potential. The subject device formulations also work to ensure the long term bond integrity by limiting the development of matrix metalloproteinases (MMP's) that have been cited as a contributor to bond degradation over time. RnD TE and RnD SE will be sold as a kit contain a 3ml bottle of RnD along with a single cavity well and Mircobrush® applicators. RnD has been designed as a single use material and is non-sterile. The material is a single component material that is applied directly to the tooth with no other components added prior to use.
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    K Number
    K131043
    Device Name
    APEX UNIVERSAL ADHESIVE
    Date Cleared
    2013-09-10

    (148 days)

    Product Code
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX DENTAL MATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Apex Universal Adhesive is a single component bonding system for: - Direct Restorations: to seal enamel / dentin prior to restoring with light-cure or self-cure . composite material - Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cements or . glass ionomer or resin-modified glass ionomer cements - Bonding CEREC® restorations . - Desensitization: to treat hypersensitive and / or exposed root surfaces . - Desensitizing crown preparations . - Sealing preparations before placing amalgams ● - Bonding crowns and bridges . - Bonding in posts and cores . - Bonding veneers .
    Device Description
    Not Found
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    K Number
    K131049
    Device Name
    ZRP
    Date Cleared
    2013-08-27

    (134 days)

    Product Code
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX DENTAL MATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ZrP is an ethanol based primer that improve the bond strengths of zirconia oxide restorations to restorative cements and bonding agents.
    Device Description
    ZrP is an ethanol based primer
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    K Number
    K120620
    Device Name
    CLEAN AND BOOST
    Date Cleared
    2012-05-31

    (91 days)

    Product Code
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX DENTAL MATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Clean and Boost is an acidic, aqueous cleanser that has been designed to help remove contaminants from the surface of a tooth prior to bonding. These contaminants can be hand piece oil, tooth debris, or imaging powder (used to create digital impressions for CAD/CAM restorations).
    Device Description
    Clean and Boost is an acidic, aqueous cleanser that has been designed to help remove contaminants from the surface of a tooth prior to bonding.
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    K Number
    K110859
    Device Name
    METAL OPAQUER
    Date Cleared
    2011-06-23

    (87 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX DENTAL MATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Metal Opaquer is a light activated (photo initiated via free radical polymerization) opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations. Metal Oapquer is a composite material which, when utilized properly, masks the metal appearance of dental implants, abutments or restorations with a tooth colored composite layer. Metal Opaquer is compatible with all other methacrylate based dental materials.
    Device Description
    Metal Opaquer is a light activated (photo initiated via free radical polymerization) opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations. Metal Oapquer is a composite material which, when utilized properly, masks the metal appearance of dental implants, abutments or restorations with a tooth colored composite layer. Metal Opaquer is compatible with all other methacrylate based dental materials.
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    K Number
    K092539
    Device Name
    SEAMFREE
    Date Cleared
    2009-10-01

    (43 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX DENTAL MATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Seamfree" is intended to be used to lubricate restorative instruments and materials. It can be used in all dental restorations and with any methylmethacrylate based material.
    Device Description
    Seamfree™ is a methylmethacrylate based resin material used as a lubricant for dental instruments and composites. The elimination of "tackiness" from dental materials makes the delivery and handling of dental composite materials faster and more consistent. Seamfree™ is activated via free radical polymerization. Seamfree is compatible with all methylmethacrylate based materials.
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    K Number
    K091647
    Device Name
    INJECTAFIL
    Date Cleared
    2009-09-21

    (104 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX DENTAL MATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material. Injectafil™ is a composite material which, when utilized properly, provides a material fordirect dental restorations. Injectafil™ can also be used as a resin cement for the delivery of indirect restorations or as a core build up material. Injectafil™ is compatible with all other methactylate based dental materials.
    Device Description
    Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material.
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    K Number
    K062157
    Device Name
    CONFORM
    Date Cleared
    2006-10-13

    (77 days)

    Product Code
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX DENTAL MATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CONFORM™ is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations. CONFORM™ is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORM™ can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORM™ is compatible with all other methacrylate based dental materials.
    Device Description
    CONFORM™ is a light activate (photo initiated, free radical polymerization), flowable hybrid composite material designed to act as a filling material in small restorations or as a liner material for larger restorations. CONFORM™ has been designed to provide a flowable material with a high level of thixotropic behavior. The material also contains fillers to optimize the cured strength and radiopacity properties. CONFORM™ is a methacrylate (BisGMA) based material that has been designed to work effectively with methacrylate based adhesives and composites currently sold into the dental market.
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    K Number
    K061981
    Device Name
    SURPASS
    Date Cleared
    2006-07-31

    (18 days)

    Product Code
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    APEX DENTAL MATERIALS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SURPASS™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light-cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resinmodified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces. Indications For Use: - Restorations: to seal enamel/dentin prior to restoring with light-cured or self-cured composite materials. - Indirect Restorations: to seal a preparation when using a light-cured, self-cured or dual-cured composite cement or glass ionomer or resin-modified glass ionomer cement. - Desensitization: to treat hypersensitive and/or exposed root surfaces. - To bond in a post and core.
    Device Description
    SURPASS™ is a light cured (free radical polymerization), self-etching dental adhesive system. designed to provide a dentist with an increased ease of use that is less technique sensitive. The bonding system combines both the etchant and primer applications into one simple step followed by a thin layer of unfilled bonding resin. Thus, allowing for more predictable clinical results without sacrificing bond strength integrity. SURPASS™ 2 is an ethanol-based adhesive that is dependent on the prepared surface of its conditioner (SURPASS™ 1). This acidic conditioner application is a procedure that is very similar to the phosphoric acid etching process of dentin/enamel substrate in the ECLIPTOMER (510K number K945604, Bisco, Inc.) system. Applying the SURPASS™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol. Once SURPASS™ 2 has been dried a thin layer of SURPASS™ 3 is applied to the SURPASS™ 2 surface and light cured for 20 seconds. The SURPASS™ 3 acts as a superior tie layer between SURPASS™2 and the filling material of choice.
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