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510(k) Data Aggregation

    K Number
    K092614
    Device Name
    X-SMART EASY
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2009-12-02

    (98 days)

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

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    X-Smart Easy is designed for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).
    Device Description
    The X-Smart Easy is an electric motor-driven handpiece intended for root canal preparation procedures in endodontic industry.
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    K Number
    K092030
    Device Name
    ELATION MB METAL REINFORCED PLASTIC BRACKET
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2009-07-24

    (18 days)

    Product Code
    DYW
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elation MB metal reinforced plastic brackets is indicated for orthodontic movement of natural teeth.
    Device Description
    The marketed product Elation Metal Reinforced Plastic Brackets has a barrel polished bonding base. A modification has been made to replace the base with the previously tested mechanical lock base and an improvement in the tie wing, Elation MB Metal Reinforced Plastic Brackets.
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    K Number
    K090454
    Device Name
    ALLURE MB CERAMIC BRACKETS
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2009-03-20

    (25 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allure® MB Ceramic Brackets and Mystique MB Ceramic Brackets are indicated for orthodontic movement of natural teeth excluding mandibular bicuspid teeth.
    Device Description
    The marketed product Allure® has a chemically treated base. A modification has been made to replace that base with a new mechanical lock base, Allure® MB. The mechanical lock base includes rhomboid and "torque-in-the-base" features.
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    K Number
    K082973
    Device Name
    STER-MATE STERILE LAVAGE KIT
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2009-01-29

    (115 days)

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

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cavitron Steri-Mate Handpiece Sterile Lavage Kit is indicated for use with the DENTSPLY Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery.
    Device Description
    The Cavitron® Steri-Mate® Handpiece Sterile Lavage Kit is an accessory for Cavitron® Ultrasonic Scalers that use the 30K Steri-Mate® Sterilizable Handpiece. This kit is intended to provide the clinician with a method to use sterile lavage with a Cavitron® Ultrasonic Scaler. The kit consists of a pressurized infuser bag and a Steri-Mate Handpiece Adapter. The Pressurized Infuser bag can be hung from a standard IV pole or similar device. The Steri-Mate Handpiece Adapter is easily installed between the handpiece cable and the Steri-Mate Handpiece. The adapter does not affect the operation of the Cavitron® Unit or the Steri-Mate Handpiece.
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    K Number
    K082974
    Device Name
    MYSTIQUE MB CERAMIC BRACKETS
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2008-11-07

    (32 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
    Device Description
    The Orthodontic Ceramic Bracket is in commercial distribution and consists of a chemically treated base. The modification to the Orthodontic Ceramic Bracket consists of a mechanical lock base and the brackets: are referred to as the Mystique MB Ceramic Brackets. Mystique MB Ceramic Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The mechanical lock base includes rhomboid and "torque-in-the-base" features. The bracket is transparent and has indented walls and is available with or without glass coating in the wire slot.
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    K Number
    K081291
    Device Name
    PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2008-05-22

    (15 days)

    Product Code
    DYH, EJF, NJM
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.
    Device Description
    The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and the adhesives described in K061252. Components of this system are used exactly as described in K061252 (Pre-cemented Orthodontic Bracket System) with the same fundamental technology and for the same intended use. This modification adds a second ceramic orthodontic bracket to the Pre-cemented Orthodontic Bracket System (K060837).
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    K Number
    K080311
    Device Name
    MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2008-04-18

    (72 days)

    Product Code
    EBG, EBD
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modified TempRx Esthetic Provisional System is: - · Indicated for the fabrication of all provisional dental restorations for a term of use of up to 6 months. - · Indicated for fabrication of the following long-term provisional dental restorations (without metal substructures) for a term of use greater than 6 months up to 3 years: - Inlays/ Onlays - Veneers - Crowns - 3-unit bridges through the 2nd bicuspid. · Indicated for the build up of a tooth on denture base resins.
    Device Description
    The Modified TempRx Esthetic Provisional System is a visible light cured composite based resin and accessories used to create provisional restorations for patients waiting for final prosthodonic restorations.
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    K Number
    K080246
    Device Name
    COMPOSITE ALIGNER BUTTON
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2008-04-11

    (71 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COMPOSITE ALIGNER BUTTON is an accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.
    Device Description
    The COMPOSITE ALIGNER BUTTON is made of plastic and is bonded to an aligner for attaching elastics and other appliances.
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    K Number
    K080203
    Device Name
    MTA ROOT CANAL SEALER
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2008-03-26

    (58 days)

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

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MTA ROOT CANAL SEALER is indicated for use for the permanent sealing of root canals of teeth and may be used in combination with root canal obturation materials.
    Device Description
    The MTA ROOT CANAL SEALER is a powder and liquid root canal sealer system. The combination of the powder and liquid creates a colloidal gel that solidifies to form a strong impermeable barrier to seal off pathways of communication between the root canal system and external surfaces of the tooth.
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    K Number
    K073173
    Device Name
    SELF-ADHESIVE RESIN CEMENT
    Manufacturer
    DENTSPLY INTERNTIONAL
    Date Cleared
    2008-01-23

    (71 days)

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

    DENTSPLY INTERNTIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.
    Device Description
    Self-adhesive Resin Cement consists of a base paste and a catalyst paste, mixed to form a dual-curing cement. The Cement is available in five shades and is delivered in double-barrel syringes and unit dose systems.
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