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510(k) Data Aggregation

    K Number
    K160232
    Device Name
    Disposable Barrier Sleeves and Covers
    Manufacturer
    DENTSPLY International Inc.
    Date Cleared
    2016-06-07

    (127 days)

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

    DENTSPLY International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Barrier Sleeves and Covers are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
    Device Description
    The proposed devices. Disposable Barrier Sleeves and Covers, are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves and covers are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The Disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment and/or protrusion (where applicable) of those parts of the devices used during dental procedures. The Disposable Barrier Cover is placed over equipment, such as dental chair head rests and trays, to cover those parts. The proposed devices, Disposable Barrier Sleeves and Covers, act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.
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    K Number
    K151619
    Device Name
    Prime&Bond Elect Universal Dental Adhesive
    Manufacturer
    DENTSPLY INTERNATIONAL INC.
    Date Cleared
    2015-10-30

    (136 days)

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

    DENTSPLY INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Prime&Bond Elect® Universal Dental Adhesive (visible light cured): - 1.1 Direct, light cured composite and compomer restorations - 1.2 Indirect restorations; light cured, resin cemented veneers - 1.3 Indirect restorations; acid-tolerant resin cement (dual cure or self-cure) cemented inlays, onlays, crown and bridge retainers - 1.4 Composite, ceramic and amalgam repairs - 1.5 Cavity varnish for use with fresh amalgam - 2. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator (dual cure or self-cure): - 2.1 Direct, dual cure or self-cure composite restorations and core build-ups - 2.2 Indirect restorations; dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers - 2.3 Dual cured and self-cured resin cemented endodontic post cementation - 3. Prime&Bond Elect® Universal Dental Adhesive mixed with Self-Cure Activator and Amalgam Bonding Base & Catalyst: - 3.1 Adhesive bonding of direct amalgam restoration - 4. Prime&Bond Elect® Universal Dental Adhesive (without Self-Cure Activator or adhesive curing): - 4.1 Indirect restorations: acid-tolerant resin cement light-cured cementation; light transmissible inlays, onlays, crown and bridge retainers with light curing of cement - 4.2 Indirect restorations; acid-tolerant resin cement dual cure or self-cure cementation; limited light/light opaque inlays, onlays, crown and bridge retainers and endodontic posts with total etch technique
    Device Description
    Prime&Bond Elect® Universal Dental Adhesive is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic. Prime&Bond Elect® Universal Dental Adhesive combines etchant, primer and adhesive in a one-bottle material. This robust formulation allows the operator to utilize selective phosphoric acid etching of enamel, phosphoric acid etching of both enamel and dentin, or no phosphoric acid etching prior to application, ensuring high bond strength and protection against microleakage. When mixed with Self-Cure Activator, Prime&Bond Elect® Universal Dental Adhesive is designed to be used with DENTSPLY manufactured dual cure/self-cure resin cements* to bond all indirect restorations and DENTSPLY manufactured dual cured composite restoratives. When used with the Amalgam Bonding Accessory Kit, available separately, Prime&Bond Elect® Universal Dental Adhesive also adhesively bonds fresh amalgam to enamel and dentin. *Note: Acid-tolerant resin cements may be used following application of Prime&Bond Elect® adhesive without the use of Self-Cure Activator, additionally allowing operator's choice of pre-cementation adhesive curing options (see complete Directions for Use).
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    K Number
    K142178
    Device Name
    PROROOT MTA WHITE, PROROOT MTA GRAY
    Manufacturer
    DENTSPLY INTERNATIONAL INC.
    Date Cleared
    2015-02-26

    (202 days)

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

    DENTSPLY INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - A root end filling material - For the repair of repair of root canals as an apical plug during apexification - For repair of root perforations during root canal therapy or as a consequence of internal resorption - As a pulp capping material - Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations
    Device Description
    ProRoot MTA White and ProRoot MTA Gray is a powder consisting of fine hydrophilic particles that set in the presence of moisture. Hydration of the powder creates a colloidal gel that solidifies to form a strong impermeable barrier that fully cures over a four-week period.
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    K Number
    K131907
    Device Name
    RAYPEX 6
    Manufacturer
    DENTSPLY INTERNATIONAL INC.
    Date Cleared
    2014-01-31

    (219 days)

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

    DENTSPLY INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RAYPEX® 6 is a microprocessor controlled device used for locating the apex.
    Device Description
    RAYPEX® 6 is a dental apex locator intended for precise localization of root canal apex. The measurements in RAYPEX® 6 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated and not mixed, eliminating the need for signal mixing and frequency discrimination electronic circuits. The patented signal measuring method utilized in RAYPEX® 6 is based on measurements of RMS (Root Mean Square) level of the signal. Advanced user interface implemented in RAYPEX® 6 is based on high resolution touch TFT (Thin Film Transistor) color graphic display with touch panel. RAYPEX® 6 provides clear real time presentation of endodontic file movement inside the canal. RAYPEX® 6 shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. File tracking algorithm enables full-scale display of the file movement during the treatment while Apical Zoom feature enables high-resolution indication of the file advance in pre-apical and apical zones. Large, clearly recognizable graphical readings in Apical Zoom are designed to enable precise control over the file advance matching the individual technique of the dentist. Visual information is accompanied by optional audio signals. The bars shown in the Apical Zoom do not represent actual distance from the apex in mm: they serve as a convenient reference to judge the file tip position in relation to the apex. Operation of RAYPEX® 6 is fully automatic. no manual calibrations or adjustments are required. The measured signal is analyzed and automatic adjustments are made if required. The device may operate within different conditions in the root canal: dry or wet. Built-in Demo mode of RAYPEX® 6 enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device. Optional verification of proper operation of RAYPEX® 6 is possible through built-in Check mode which enables easy automatic check-up of both the device and its accessories. For practitioner's convenience the following user interface features may be set through RAYPEX® 6 device setup menu: display background color, preferred sound type and display brightness.
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    K Number
    K121698
    Device Name
    NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
    Manufacturer
    DENTSPLY INTERNATIONAL INC.
    Date Cleared
    2012-08-06

    (59 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures, including prior to and after scaling and root planing as part of a professionally administered dental prophylaxis treatment. Secondarily, NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity and for lasting sensitivity relief for up to 4 weeks (28 days) after just one application.
    Device Description
    NUPRO® Sensodyne® is a premium prophylaxis paste containing NovaMin®, a calcium sodium phosphosilicate. The dye-free formulations are available in fluoride and non-fluoride formulations, with two different grits to gently remove dental plaque and stains. The Polish Grit is ideal for prophy procedures requiring minimal tooth abrasion. The Stain Removal Grit is suitable for most cleaning procedures where a high level of polish is desired for stain removal.
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    K Number
    K103653
    Device Name
    E3 TORQUE CONTROL MOTOR
    Manufacturer
    DENTSPLY INTERNATIONAL INC.
    Date Cleared
    2011-05-26

    (164 days)

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

    DENTSPLY INTERNATIONAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The e3 Torque Control Motor is a medical device designed for use by dentists for use with dental root canal instruments in continuous rotation with torque control or in reciprocating movement.
    Device Description
    The e3 Torque Control Motor is an electric motor-driven handpiece intended for the endodontic industry. It works in both reciprocating mode and continuous rotation. This motor is provided with pre-programmed settings for the most popular nickel titanium rotary file systems sold by DENTSPLY. The dentist is also able to program 15 settings of their choice for speed and torque control. The device consists of a control unit with an LCD screen for selection of settings. A foot pedal is connected to the control unit so the dentist can selectively activate the motor. A power supply is also connected to the control unit to allow the dealer to charge the battery. The motor is connected to the control unit and a 6:1 contra angle. Files attach to the contra angle.
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