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510(k) Data Aggregation

    K Number
    K140846
    Device Name
    EDS COMBO-RINSE
    Manufacturer
    ESSENTIAL DENTAL SYSTEMS, INC.
    Date Cleared
    2014-07-25

    (113 days)

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

    ESSENTIAL DENTAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EDS Combo-Rinse is intended to cleanse root canal systems by irrigating root canals.
    Device Description
    EDS Combo-Rinse is an aqueous solution for use during the irrigation phase of endodontic root canal preparation procedures. The device has a dual purpose of flushing out any loosened debris and removing the smear layer produced from root canal instrumentation.
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    K Number
    K132609
    Device Name
    EDS ULTRASONIC TIPS
    Manufacturer
    ESSENTIAL DENTAL SYSTEMS, INC.
    Date Cleared
    2014-01-22

    (155 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSENTIAL DENTAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EDS Ultrasonic Tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra-canal blockages.
    Device Description
    EDS Ultrasonic Tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. These powered components are not included as part of the device submitted for application with the 510(k) submission. EDS Ultrasonic Tips are stainless steel and will be available in M3x0.5 and #5-40 thread with 6 different tip designs. 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals.
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    K Number
    K111541
    Device Name
    ENDO-EXPRESS (R) HANDPIECE
    Manufacturer
    ESSENTIAL DENTAL SYSTEMS, INC.
    Date Cleared
    2012-03-16

    (288 days)

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

    ESSENTIAL DENTAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endo-Express® Handpiece is indicated for the removal of dentin, shaping and obturation of the root canal. This application area extends to endodontic procedures using NiTi or stainless steel endodontic instruments intended by the manufacturer for use in the mechanical preparation of root canals.
    Device Description
    Endo-Express® Handpiece is a reciprocating handpiece for use with NiTi or stainless steel instruments during endodontic procedures. The handpiece is driven by an air motor. The steps required to properly operate the handpiece are: push button to open chuck, insert instrument handle into chuck, release button to close chuck, run handpiece. After use, the handpiece should be lubricated and autoclaved. The contents of the kit are 1 Endo-Express® Handpiece, 1 Lubricant bottle, 1 nozzle attachment.
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    K Number
    K101504
    Device Name
    TI-CORE FLOW
    Manufacturer
    ESSENTIAL DENTAL SYSTEMS, INC.
    Date Cleared
    2010-10-29

    (150 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSENTIAL DENTAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ti-Core® Flow+ is indicated for vital or non-vital tooth core build-up (replacement of existing restorations and/or lost tooth structure), as a base prior to fabricating an indirect restoration, and as a post cement. Ti-Core® Flow+ is also indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, and for core build-ups.
    Device Description
    Ti-Core® Flow+ is a dual-cure resin cement that can be used as a luting agent and core material. It is packaged in the familiar double-barrel syringe and our materials with the puttless other dental materials. The steps required to oroperly express the cement are: remove cap, attach mixer, attach dispensing tip, press plunger. After use, the mixer/dispensing tip should be discarded and the cap replaced. The contents of the kit are 2 - Dual chambered syringes each containing 9 am resin cement - 20 Mixers 10 - Thin dispensing tips 10 - Thick dispensing tips
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    K Number
    K072555
    Device Name
    EDTA PLUS
    Manufacturer
    ESSENTIAL DENTAL SYSTEMS, INC.
    Date Cleared
    2007-12-13

    (94 days)

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

    ESSENTIAL DENTAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EDTA Plus is a root canal cleanser designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation
    Device Description
    EDTA Plus is a root canal cleanser for use in endodontic procedures. During/After endodontic instrumentation, the product should be used to clean the canal space and remove the smear layer before placement of the endodontic filling. The material can be delivered into the canal using a side-vented, closed tip irrigation needle. The device consists of a 16 oz. bottie of EDTA Plus, a peach-colored aqueous solution.
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    K Number
    K070401
    Device Name
    ENDO-CHX
    Manufacturer
    ESSENTIAL DENTAL SYSTEMS, INC.
    Date Cleared
    2007-07-11

    (149 days)

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

    ESSENTIAL DENTAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENDO-CHX™ is intended to irrigate and cleanse root canal systems.
    Device Description
    Endo-CHX™ is a root canal cleanser for use in endodontic procedures. After endodontic instrumentation, the product 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 neede. A side-vented, closed tip irrigation needle is most preferred.
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    K Number
    K063856
    Device Name
    EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
    Manufacturer
    ESSENTIAL DENTAL SYSTEMS, INC.
    Date Cleared
    2007-02-06

    (40 days)

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

    ESSENTIAL DENTAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZ-Fill® Xpress Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.
    Device Description
    The EZ-Fill® Xpress Epoxy Root Canal Cement System is an obturation system for filling straight and minimally curved canals. The bi-directional spiral (cement carrier that fully coats the canal, but prevents excess cement form exiting apically) and epoxy root canal cement, combined with a single point technique, creates a seal equivalent to lateral condensation and thermoplastic gutta percha. The contents of the kit are identical except that '2 - Dual Chambered Syringes containing 9.5 gm of root canal sealer' and '20 - Mixing Tips' replace the '7.5 gm - Epoxy Root Canal Cement Gel, 8.0 gm - Powder (Epoxy Root Canal Cement), and 1 Measuring Scoop.' The full list of contents is as follows: 4 - Color Coded to ISO Size 25 Bi-Directional Spirals (1 - 21mm length and 3 - 25 mm length), 2 - Dual Chambered Syringes containing 9.5 gm root canal sealer, 20 - Mixing Tips.
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