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510(k) Data Aggregation

    K Number
    K162662
    Device Name
    GingiDent Gingival Retraction Paste
    Manufacturer
    PAC-DENT INTERNATIONAL, INC.
    Date Cleared
    2017-10-20

    (389 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAC-DENT INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, taking an impression, cementation and cavity preparation.
    Device Description
    GingiDent gingival retraction paste is an astringent formulated to provide gingival retraction and hemostasis. GingiDent gingival retraction paste contains Aluminum Chloride and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. This product is a blue-green paste developed exclusively for transient surgically invasive use in the oral cavity. The paste contains Aluminum Chloride in a water-based clay inert carrier.
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    K Number
    K160577
    Device Name
    PacEndo Chlorhexidine
    Manufacturer
    PAC-DENT INTERNATIONAL, INC.
    Date Cleared
    2016-07-25

    (146 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAC-DENT INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PacEndo™ Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation.
    Device Description
    PacEndo™ Chlorhexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.
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    K Number
    K151123
    Device Name
    Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
    Manufacturer
    Pac-Dent International, Inc.
    Date Cleared
    2016-03-03

    (310 days)

    Product Code
    PEM
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pac-Dent International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pac-Dent Barrier Sleeve and Cover-It Barrier Film are intended to be used as a barrier to cover dental instruments. This device is non-sterile and is intended for single patient use only.
    Device Description
    Pac-Dent Barrier Sleeve and Cover-It™ Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.
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    K Number
    K153528
    Device Name
    PacEndo EDTA
    Manufacturer
    PAC-DENT INTERNATIONAL, INC.
    Date Cleared
    2016-02-01

    (54 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAC-DENT INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PacEndo™ EDTA is intended to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
    Device Description
    PacEndo™ EDTA is an EDTA solution in water with surfactant to lower surface tension. The solution is a root canal cleanser for use in endodontic procedures to remove the smear layer produced from root canal instrumentation.
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    K Number
    K151852
    Device Name
    PacEndo Sodium Hyprochlorite
    Manufacturer
    PAC-DENT INTERNATIONAL, INC.
    Date Cleared
    2015-11-10

    (126 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAC-DENT INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PacEndo™ Sodium Hypochlorite is intended to irrigate, cleanse, and debride root canal systems. It is also intended to provide irrigation during root canal instrumentation.
    Device Description
    PacEndo™ Sodium Hypochlorite is a Sodium Hypochlorite solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.
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    K Number
    K151150
    Device Name
    Elements
    Manufacturer
    PAC-DENT INTERNATIONAL, INC.
    Date Cleared
    2015-07-28

    (89 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAC-DENT INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elements™ is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.
    Device Description
    Elements™ is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.
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    K Number
    K141717
    Device Name
    PACSEAL PIT & FISSURE SEALANT
    Manufacturer
    PAC-DENT INTERNATIONAL, INC.
    Date Cleared
    2015-03-09

    (257 days)

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

    PAC-DENT INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PacSeal™ Pit & Fissure Sealant is intended for use as: - Seal the pits and fissures in teeth
    Device Description
    PacSeal™ Pit & Fissure Sealant is a fluoride releasing, light-cured acrylate resin designed to fill and seal the pits and fissures of teeth.
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    K Number
    K141422
    Device Name
    PROFLUORO FLUORIDE VARNISH
    Manufacturer
    PAC-DENT INTERNATIONAL, INC.
    Date Cleared
    2014-09-30

    (123 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    PAC-DENT INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProFluoro™ Fluoride Varnish is intended for use as: - Professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film
    Device Description
    ProFluoro™ Fluoride Varnish is a resin-based 5% sodium fluoride varnish applied to tooth surfaces with an applicator brush. Moisture from saliva cures the varnish and leaves a film on tooth to treat tooth hypersensitivity.
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    K Number
    K130672
    Device Name
    OPTIFLOW II FLOWABLE COMPOSITE, LC
    Manufacturer
    PAC-DENT INTERNATIONAL, INC.
    Date Cleared
    2013-08-13

    (154 days)

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

    PAC-DENT INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiFlow II Flowable Composite, LC is intended for use as: - Repair of minimally invasive cavity (including non-stress bearing areas) - Pit and fissure sealant - Class III-V restorations - Repair of porcelain restorations - Repair of ceramic/composite veneers
    Device Description
    OptiFlow II Flowable Composite, LC is a light cure resin-based flowable restorative dental composites. The restorative is packaged in capsules and syringes. The fillers are a combination of radiopaque inorganic fillers and advanced nano-silicas with an average particle size of 0.7 microns to produce a loading approximately 57% by weight (40% by volume). All shades have a radiopacity of 200%.
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