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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
    K123615
    Device Name
    IRIS - HIGH STRENGTH GLASS CERAMIC
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2013-02-22

    (91 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IRIS - High Strength Glass Ceramic is a system of precrystallized and/or fully crystallized zirconia reinforced lithium silicate glass ceramics and veneering ceramics processed through CAD-CAM techniques for the fabrication of: Single unit dental restorations, for example all-ceramic crowns, inlays, onlays and veneers. IRIS can be used as a substructure which is then veneered with IRIS veneering ceramic or can be used for full-contour application (without veneering) as well.
    Device Description
    IRIS - High Strength Glass Ceramic is a system of glass ceramic dental materials based on zirconia reinforced lithium silicate chemistries and feldspathic veneering ceramics and accessories optimized to be compatible with IRIS glass ceramics. The system consists of: A. IRIS Flex: High Strength Glass Ceramic (HSGC) CAD CAM blanks provided in the fully crystallized state, for machining and subsequent placement. B. IRIS CAD: High Strength Glass Ceramic (HSGC) CAD CAM blanks provided in the partially crystallized state, for machining, crystallization firing, and subsequent placement. C. Veneering ceramics provided in powder/paste forms and are intended for optional esthetic characterization of the CAD CAM restorations. IRIS materials may be veneered with a compatible dental veneering ceramic or can be used as anatomically shaped full-contour restorations without veneering.
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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
    K072730
    Device Name
    FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2008-03-27

    (183 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSPLY INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FRIADENT® CERCON® Abutment is indicated for the support of exceptionally esthetic, single crowns in the anterior region of the maxilla or mandible region. Also ideal for XiVE®, FRIALIT® or FRIALIT®-2 cases involving very thin soft tissue. The ANK YLOS® CERCON® Abutment is indicated for the support of highly esthetic single tooth crowns in the anterior region of the maxilla and mandible, including where the mucosa is very thin, in combination with implants of the ANKYLOS® implant system.
    Device Description
    The CERCON® ABUTMENTS are part of the FRIADENT® prosthetics. The CERCON® ABUTMENTS are available as straight and angled abutments with different gingival margins and in multiple diameters and shades.
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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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