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510(k) Data Aggregation

    K Number
    K140347
    Device Name
    ANKYLOS C/X IMPLANT SYSTEM
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2014-08-20

    (190 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ANKYLOS® C/X Implants of 8 mm in length or longer are for single-stage or two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement and function on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted. ANKYLOS® C/X Implants of 6.6 mm in length are for two-stage surgical procedures and cemented, removable or screw retained restorations. The ANKYLOS® C/X Implants may be used for immediate placement on single tooth and/or multiple tooth applications when adequate primary stability is achievable, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted.
    Device Description
    The ANKYLOS® C/X Implant 6.6 mm represents a line extension of the currently marketed ANKYLOS® C/X Dental Implant System. It is an endosseous dental implant with a length of 6.6 mm and an internal tapered implant-abutment connection. The ANKYLOS® C/X Implant 6.6 mm is machined from Commercially Pure (CP) Grade 2 Titanium (conforming to ASTM F67 -Standard Specification for Unalloyed Titanium, for Surgical Implant Applications). The ANKYLOS C/X 6.6 mm implants are provided in the diameters 3.5 mm, 4.5 mm, and 5.5 mm.
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    K Number
    K130862
    Device Name
    CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2013-07-23

    (117 days)

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

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for: - . Stain removal, - Prophylaxis of orthodontic patients, . - Preparing tooth surfaces prior to bonding and sealant procedures, and ● - Implant debridement .
    Device Description
    The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is an air polishing unit that delivers an air/water/powder mixture at the air polishing insert tip that polishes the tooth enamel without direct contact of the device. The system is used with water-soluble prophy powders such as Cavitron® PROPHY-JET® Sodium Bicarbonate Prophy Powder (K970342) or Cavitron® JET-Fresh® Aluminum Trihydroxide Prophy Powder (K014188) (for patients with low sodium requirements). Updated design features on the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System include a Tap-On™ Wireless Foot Pedal, prophy mode auto cycles, an illuminated diagnostic display, automated purge function, Cavitron® JET-Mate™ detachable sterilizable handpiece (K023697), and a swivel handpiece cable with more precise lavage control. Upon installation, the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System unit is connected to external air and water lines, as well as an AC power cord.
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    K Number
    K103244
    Device Name
    QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2011-02-14

    (104 days)

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

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system after endodontic instrumentation.
    Device Description
    QMix™ 2in1 Endodontic Irrigating Solution is a premixed dual-action device that cleanses and disinfects the root canal system by removing the smear layer and killing bacteria after endodontic instrumentation.
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    K Number
    K093221
    Device Name
    PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2009-10-30

    (17 days)

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

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pre-Cemented Orthodontic Bracket System Extension II is indicated for use in bonding orthodontic appliances for orthodontic treatment.
    Device Description
    The Pre-Cemented Orthodontic Bracket System Extension II is comprised of precemented ceramic and metal orthodontic brackets, transfer tray and adhesives.
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    K Number
    K083805
    Device Name
    ANKYLOS C/X DENTAL IMPLANT SYSTEM
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2009-05-22

    (151 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANKYLOS® C/X Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.
    Device Description
    The new ANK YLOS® C/X Dental Implant System introduces a new configuration of the current ANKYLOS® plus dental implant line. The new line extension includes the: ANKYLOS® C/X Implant, ANK YLOS C/ Regular Abutments, ANKYLOS /X Regular Abutments, ANKYLOS® Regular C/X Gingiva Former, and the ANK YLOS® Titanium Alloy Screws (Membrane Screw and Fixation Screw). The ANKYLOS® C/X Dental Implant was modified to integrate an indexation into the taper connection to provide a precise position of the abutment. With the new index, the relocation of the abutment is possible without using a transfer-kev for the impressions taking.
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    K Number
    K082198
    Device Name
    DURASHIELD PLUS
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2008-10-29

    (86 days)

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

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DURASHIELD® PLUS is indicated for the relief of dental hypersensitivity where dentin and cementum are exposed.
    Device Description
    DURASHIELD® PLUS is a topically applied, flavored cavity varnish containing sodium fluoride and NovaMin. The varnish is a viscous liquid and is insoluble in water and saliva. NovaMin is a bio-available calcium phosphosilicate that releases calcium and phosphorous when exposed to moisture.
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    K Number
    K072989
    Device Name
    AXIS SYSTEM
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2008-01-28

    (97 days)

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

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axis System is an air-powered dental handpiece system indicated for use in general dentistry.
    Device Description
    The Axis System consists of air-powered dental handpieces with an electronic accessory to limit the speed.
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    K Number
    K073117
    Device Name
    DENTIN DESENSITIZER AGENT
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2007-12-19

    (44 days)

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

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treating and preventing dentinal hypersensitivity. Can be used under direct restorations, under indirect restorations, and on cervical sensitivity.
    Device Description
    The DENTIN DESENSITIZER AGENT is a chair-side agent for treating and preventing dentinal hypersensitivity.
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    K Number
    K062828
    Device Name
    MOUTHGUARD AND ALIGNER MATERIALS
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2006-11-27

    (68 days)

    Product Code
    MQC, EBG, KMY, NXC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MOUTHGUARD AND ALIGNER MATERIALS are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
    Device Description
    MOUTHGUARD AND ALIGNER MATERIALS are plastic, resin, or laminate materials that are sold for the purpose of making various dental and/or orthodontic appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges. Each material is indicated for the fabrication of orthodontic and dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the sheets are thermoformed and trimmed to create custom devices or appliances.
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    K Number
    K060836
    Device Name
    VISTADENT OC - VERSION 4
    Manufacturer
    DENTSPLY INTL., INC.
    Date Cleared
    2006-10-27

    (213 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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