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510(k) Data Aggregation

    K Number
    K202674
    Device Name
    Medidenta High Speed Handpieces
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2022-12-12

    (818 days)

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

    Pac-Dent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medidenta High Speed Handpieces are intended for removing carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are by a trained professional in the field of general dentistry.
    Device Description
    Not Found
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    K Number
    K202920
    Device Name
    OptiComp
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2022-05-25

    (603 days)

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

    Pac-Dent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiComp is a light cured hybrid dental restorative composite material used for direct restorations in all classes of cavities, including veneers and incisal edge repairs, and indirect anterior restorations, including inlays, onlays, and veneers.
    Device Description
    Not Found
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    K Number
    K202831
    Device Name
    The iMask Child's Face Mask
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-08-26

    (335 days)

    Product Code
    OXZ
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pac-Dent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iMask Child's Face Mask is intended to be worn by the patient/child (recommended ages 4-12) to provide protection for the respiratory tract. This is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
    Device Description
    Not Found
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    K Number
    K210189
    Device Name
    Pac-Dent Denture Base Resin
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-07-28

    (184 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pac-Dent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pac-Dent Denture Base resin is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins.
    Device Description
    Pac-Dent Denture Base resin is a light-curable resin.
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    K Number
    K210412
    Device Name
    Pac-Dent Ceramic Nanohybrid Resin
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-07-26

    (165 days)

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

    Pac-Dent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pac-Dent Ceramic Nanohybrid Resin is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabrications such as inlays, onlays, veneers and full crown restorations.
    Device Description
    Not Found
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    K Number
    K210186
    Device Name
    PacBond One
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-07-16

    (172 days)

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

    Pac-Dent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Direct Indications: 1. light-cured composite and compomer restorations 2. composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations 3. light-cured or dual-cured core build-ups Indirect Indications: 1. veneers, porcelain, composite, and metal-based inlays, onlays, crowns, bridges endodontic posts 2. cavity sealing as a pretreatment for indirect restoration
    Device Description
    Not Found
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    K Number
    K201182
    Device Name
    iMask Disposable Surgical Face Mask
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-02-19

    (294 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pac-Dent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iMask Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided nonsterile.
    Device Description
    Not Found
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