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510(k) Data Aggregation

    K Number
    K071632
    Device Name
    PERFECT TISSUE CONTOURING SYSTEM II
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2007-10-18

    (126 days)

    Product Code
    EKZ
    Regulation Number
    872.4920
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PerFect® TCS II is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity.
    Device Description
    PerFect® TCS II is an electrosurge unit designed to appeal to both the new and experienced user of electrosurgery. PerFect® TCS II can simplify and enhance the results of a variety of everyday procedures performed by virtually every dentist, including the control of bleeding, gaining access to caries and aesthetic contouring of gingiva. The PerFect® TCS II is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The radio-frequency energy used by PerFect® TCS II is able to sever and coagulate tissue because it focuses the heat energy at the small, active electrode. While the active electrode remains cold, sufficient heat energy is generated in its path to sever and coagulate effectively. The high-frequency energy focused at the active electrode returns to the electrosurge through the large dispersive electrode, which is placed on the back of the dental chair against the patient's back during use. The PerFect® TCS II has two output modes: "Cut" and "Coag." The operator can adjust the intensity of these modes. When the power output is adjusted properly, the electrode cuts without resistance, permitting an extraordinary degree of control and precision. The PerFect® TCS II is designed to use the Strobex (predicate) handpiece electrodes. These handpiece electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing process. In addition performance testing was conducted by UL that included functional testing of electrodes sterilized twenty times via the recommended cycle.
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    K Number
    K051660
    Device Name
    DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2005-08-04

    (43 days)

    Product Code
    KMH
    Regulation Number
    880.6870
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DDS 7000 is a countertop convective dry heat sterilizer designed for use in Healthcare facilities for the sterilization of un-bagged dental instruments that can withstand exposure temperatures up to 216°C (420° F). There is a single software-controlled cycle that includes a warm-up and cool down phase in addition to the 3-minute sterilization (exposure) phase. Sterilize (exposure) starts when the RTD/control temperature reaches the operating temperature set point of 190°C (374° F). Complete cycle times average 34-44 minutes and are load dependent. The DDS 7000 achieves optimum results by uniform load distribution utilizing a dedicated rack and tray system as detailed below. 1) Maximum recommended loads validated for the DDS 7000-115 sterilizer: - a) Maximum load for a four (4)-rack configuration is four (4) plier racks each holding nine (9) orthodontic pliers each for a total of thirty-six (36) pliers. Other maximum load configuration options are: 32 pliers on eight mini vertical racks; or 20 pliers and hand instruments on four Combo Racks -(OR)- b) Maximum load for a full tray configuration is one (1) Horizontal Tray each holding up to six (6) orthodontic pliers or up to (12) single-handle hand instruments. Other maximum load combinations include: (5) orthodontic pliers with up to (2) single-handle hand instruments; or (4) orthodontic pliers with up to (4) single-handle hand instruments; or (3) orthodontic pliers with up to (6) single-handle hand instruments, or (2) Orthodontic pliers with up to (8) single-handle hand instruments; or (1) Orthodontic pliers with up to (10) single-handle hand instruments. - (OR)- c) Maximum load for the one (1) half tray and two (2) racks is one (1) Half Tray holding three (3) Orthodontic pliers or six (6) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks. Other maximum load combinations include: (2) orthodontic pliers with up to (2) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks; or (1) orthodontic pliers with up to (4) singlehandle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks.
    Device Description
    The DDS 7000, like the DDS 5000 is a convective dry heat batch sterilizer capable of sterilizing un-bagged dental instruments and cooling them for immediate use. It is designed for use with a dedicated rack system that provides for uniform loading to achieve optimum load distribution. The DDS 7000 is equipped with a replaceable HEPA filter to comply with ANSI/AAMI ST50: 2004 cooling requirements. The HEPA filter has a filtration efficiency of 99.7% for 0.3-micron particles. The DDS 7000 is a software-controlled device that allows for the user to preprogram options such as display units (Celsius or Fahrenheit), audible alarm enabled/disabled and safety interlock enabled/disabled The DDS 7000 monitors the entire cycle and will provide diagnostic error codes in the event of any failure or disruption to the sterilization cycle. A printable log is available for the most recently performed cycle that includes pass/fail notification and error codes if applicable
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    K Number
    K040551
    Device Name
    COLTOLUX LED CURING LIGHT
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2004-03-15

    (13 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for the polymerization of intra oral and extra oral restorations fabricated from materials [commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives ] that contain Camphorquinone as the photo initiator.
    Device Description
    Not Found
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    K Number
    K033760
    Device Name
    ONE COAT SE BOND
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2004-01-23

    (52 days)

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

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    One Coat SE Bond, a self etching dental adhesive, is indicated for the following: - The bonding of indirect restorations (inlays, onlays, veneers, when used with . lightcure or dual cure luting cements) to tooth structure. - The bonding of direct fillings of composite or compomer. . - The bonding of composite to amalgam. . - The repairing of metal/ceramic, ceramic or composite restorations. . - The sealing of sensitive teeth. .
    Device Description
    Not Found
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    K Number
    K031752
    Device Name
    COLTOSOL F
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2003-08-05

    (61 days)

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

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary fillings of Class I and II cavities. Temporary sealing in endodontics.
    Device Description
    Not Found
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    K Number
    K013400
    Device Name
    SYNERGY FLOW
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2001-12-10

    (56 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Class II, IV fillings in anterior teeth; Small fillings in posterior teeth; Fillings of minimal cavities; Blocking out undercuts
    Device Description
    Not Found
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    K Number
    K003034
    Device Name
    COLTENE AURA COMPOMER RESTORATIVE SYSTEM
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2000-11-30

    (63 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993545
    Device Name
    TENAX WHITE POST
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2000-04-14

    (178 days)

    Product Code
    ELR
    Regulation Number
    872.3810
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tenax White Posts are for use where ever endodontic posts are required and where esthetic considerations and/or where known allergies to metals are of concern.
    Device Description
    Not Found
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    K Number
    K000311
    Device Name
    PARAPOST FIBER WHITE
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2000-03-14

    (42 days)

    Product Code
    ELR
    Regulation Number
    872.3810
    Why did this record match?
    Applicant Name (Manufacturer) :

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993710
    Device Name
    MODIFICATION OF PARAPOST CEMENT
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    1999-12-21

    (48 days)

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

    COLTENE/WHALEDENT INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ParaCem cement is for the discretionary use by dentists for the permanent cementation of endodontic posts into root canals after endodontic therapy has been completed.
    Device Description
    Not Found
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