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510(k) Data Aggregation

    K Number
    K250279
    Device Name
    RC-SwiftPrep
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2025-07-02

    (152 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K241354
    Device Name
    Sealer Solvent
    Manufacturer
    Inter-Med, Inc.
    Date Cleared
    2024-08-27

    (106 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sealer Solvent, a root canal cleanser, is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy.
    Device Description
    The Sealer Solvent presents a clinically effective way to aid in removal of bioceramic root canal sealers during endodontic retreatment procedures. Sealer Solvent is an aqueous-based irrigant that is delivered via syringe and needle tip while instrumenting the canal after any gutta percha is removed. Sealer solvent works to soften and dissolve the sealer to be flushed out or removed with files. Although Sealer Solvent has been designed for use as a retreatment irrigant, it may be used during traditional endodontic non-retreatment procedures as an endodontic irrigant (i.e. root canal cleanser) to help remove inorganic solids from canal walls, such as smear layer and calcium hydroxide, prior to obturation.
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    K Number
    K201785
    Device Name
    EPIEN Dental Cleanser
    Manufacturer
    EPIEN Medical, Inc.
    Date Cleared
    2021-09-09

    (436 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EPIEN DENTAL CLEANSER is indicated for the following uses: 1) Caries Restoration Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of exposed dentin surfaces in cavity preparations to assist in the removal of contaminated debris and smear-layer. 2) Chronic Periodontitis Treatment Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures (scaling and root planing) to help with the removal of contaminated debris from the sulcus.
    Device Description
    Not Found
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    K Number
    K211813
    Device Name
    Triton
    Manufacturer
    Inter-Med / Vista Dental
    Date Cleared
    2021-08-18

    (68 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Triton is used for debridement, removing the smear layer, and cleansing the root canal system.
    Device Description
    Triton is a two-part, dual-action root canal cleanser. Triton Part A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. Triton Part B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed solution cleanses and debrides the root canal system by removing the organic debris during and after endodontic instrumentation.
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    K Number
    K193357
    Device Name
    V-Mix
    Manufacturer
    Inter-Med/ Vista Dental Products
    Date Cleared
    2020-10-23

    (324 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    V-Mix is used for debridement, removing the smear layer, and cleansing the root canal system.
    Device Description
    V-Mix is a two-part, dual-action root canal cleanser. V-Mix A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. V-Mix B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed, the mixed solution cleanses and debrides the root canal system by removing the organic and inorganic debris during and after endodontic instrumentation.
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    K Number
    K193409
    Device Name
    Vista Rinse, Vista Rinse Plus
    Manufacturer
    Inter-Med/Vista Dental Products
    Date Cleared
    2020-09-09

    (275 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.
    Device Description
    Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation. Both medical devices are packaged in bottles. Clinical use of the medical devices requires the irrigant to be expelled from syringes through irrigation tips, which are class I medical devices per EIC product code (syringe, periodontic, endodontic, irrigating) and CFR regulation number 872.4565 and are 510(k) exempt.
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    K Number
    K200330
    Device Name
    RC-Prime Root Canal Preparation Cream
    Manufacturer
    Pac-Dent, Inc
    Date Cleared
    2020-07-06

    (147 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RC-Prime Root Canal Preparation Cream is intended to be used by dental practitioners to cleanse and debride root canals for more efficient instrumentation during endodontic therapy.
    Device Description
    RC-Prime Root Canal Preparation Cream
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    K Number
    K173163
    Device Name
    ChlorCid, ChlorCid V, ChlorCid Surf
    Manufacturer
    Ultradent Products, Inc.
    Date Cleared
    2018-02-09

    (133 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ChlorCid, ChlorCid V and ChlorCid Surf are used for irrigating, instrumentation and debriding of root canal preparations.
    Device Description
    The ChlorCid family of products are aqueous solutions of 3% sodium hypochlorite used for endodontic procedures. When desired, ChlorCid V is a more viscous solution for enhanced flow control and lubrication, and ChlorCid Surf includes a surfactant which assists in the product's ability to penetrate in tight canal spaces.
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    K Number
    K162311
    Device Name
    Straumann PrefGel
    Manufacturer
    INSTITUT STRAUMANN AG
    Date Cleared
    2017-03-07

    (201 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    KJJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Straumann PrefGel is intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear layer.
    Device Description
    Straumann PrefGel is a neutral EDTA formulation intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear-layer. Mechanical debridement of a root surface inevitably produces a smear-layer, which in turn may prevent or retard periodontal healing. Exposure of collagen fibers may be important for linking fibrin in the blood clot to the root surface. Clinical studies with PrefGel have demonstrated the ability to remove the smear-layer and to expose the collagenous matrix of dentin surfaces.
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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?
    Product Code :

    KJJ

    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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