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510(k) Data Aggregation

    K Number
    K241489
    Device Name
    ReminGel
    Manufacturer
    Inter-Med, Inc.
    Date Cleared
    2025-01-08

    (229 days)

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

    Inter-Med, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.
    Device Description
    ReminGel is a convenient, premixed, ready-to-use, opaque aqueous-based gel. ReminGel consists of suspended hydroxyapatite and calcium and phosphate salts that help restore a tooth's hydroxyapatite structure through remineralization. This remineralization results in tubule occlusion and blocks fluid flow in dentinal tubules, thereby relieving dentinal sensitivity. ReminGel blocks nerve excitability through potassium release. ReminGel is packaged in a 3oz (90mL) tube. ReminGel is for prescription use (Rx) and over-the-counter (OTC) use. ReminGel can be applied to teeth using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush.
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    K Number
    K241457
    Device Name
    Vista BC Putty
    Manufacturer
    Inter-Med, Inc.
    Date Cleared
    2024-08-28

    (97 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inter-Med, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Repair of Root Perforation - Repair of Root Resorption - Root End Filling - Apexification - Pulp Capping
    Device Description
    Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties. 1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.
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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?
    Applicant Name (Manufacturer) :

    Inter-Med, Inc.

    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
    K221811
    Device Name
    Vista BC Sealer
    Manufacturer
    Inter-Med, Inc.
    Date Cleared
    2022-11-21

    (152 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inter-Med, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent obturation of the root canal following vital pulp-extirpation. Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
    Device Description
    Vista BC Sealer is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. Vista BC Sealer is an insoluble, radiopaque material based on a calcium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Sealer does not appreciably shrink during setting and demonstrates excellent physical properties. Vista BC Sealer is packaged in a preloaded syringe and supplied with disposable single use application tips.
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    K Number
    K211721
    Device Name
    PS System
    Manufacturer
    Inter-Med, INC.
    Date Cleared
    2021-12-02

    (181 days)

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

    Inter-Med, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
    Device Description
    The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.
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    K Number
    K112250
    Device Name
    CHX=CHX PLUS
    Manufacturer
    INTER-MED, INC.
    Date Cleared
    2011-10-28

    (85 days)

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

    INTER-MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CHX and CHX-Plus™ are used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing
    Device Description
    CHX and CHX-PlusTM are 2% Chlorhexidine Gluconate Solutions in water. CHX – PlusTM also contains wetting agents to lower surface tension. CHX and CHX-PlusTM are root canal cleansers for use in endodontic procedures. After endodontic instrumentation, these products should be used to cleanse the canal space before placement of the endodontic filling. The material should be delivered into the canal using an irrigating needle
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    K Number
    K082470
    Device Name
    SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA
    Manufacturer
    INTER-MED, INC.
    Date Cleared
    2009-04-03

    (219 days)

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

    INTER-MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sodium Hypochlorite 3% & 6% Solution and Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM are solutions used for debridement and the instrumentation of root canal. Sodium Hypochlorite-3% & 6% and Chlor-XTRATM 6% are Sodium Hypochlorite in water.
    Device Description
    Sodium Hypochlorite 3% & 6%: Solutions are 3% & 6% Sodium Hypochlorite in water. Sodium Hypochlorite 6% with wetting agents to lower surface tension marketed as Chlor-XTRATM is a Sodium Hypochlorite solution in water with alkalizing salt agents to increase the electrical capacity of the solution.
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