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510(k) Data Aggregation

    K Number
    K103708
    Device Name
    ML24000 UVA-1 PHOTOTHERAPY UNIT
    Date Cleared
    2011-02-22

    (64 days)

    Product Code
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE DAAVLIN DISTRIBUTING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
    Device Description
    The ML24000 UVA-1 Phototherapy Unit is a microprocessor controlled full body ultraviolet light source, with spectral output at peak wavelengths of 370-390 nm. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders. The desired dose is selected using the operator interface located on the front panel of the device. The ML24000 UVA-1 Phototherapy Unit delivers full body phototherapy, wherebv Philips CLEO HPA 1018 Medium Pressure Lamps, which surround the patient, deliver the specified dose of UVA-1.
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    K Number
    K052780
    Device Name
    DENTAPLAST HOT, MODEL 16-XXX
    Date Cleared
    2005-12-21

    (79 days)

    Product Code
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The bredent denture relining, repairing or rebasing resin is intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base.
    Device Description
    Dentaplast hot is a polymerizing denture resin on the basis of methylmetacrylate. Dentaplast hot allows to obtain extended processing time and offers fine flowability and is therefore matched with the Dentaplast hot casting sstem. The catalyst is free from tertiary amine and ensures high colour stability. Dentaplast is entirely cadmium-free. Application range: -Fabrication of full dentures in the resin casting technique -Completion of CoCr dentures -Relinings and shaping of functional margins -any type of repair work such as cracks, fractures.
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    K Number
    K052779
    Device Name
    BRECOMP
    Date Cleared
    2005-12-20

    (78 days)

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

    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Brecomp is intended to restore carious lesions or structural defects in teeth.
    Device Description
    Bre.comp dentine/enamel/transparent is a light curing microhybride for anterior and posterior restorations. Bre.comp is based on BIS-GMA resins and inorganic fillers with particle size of 0.05 to 0.09 µm. The total filler content is 81% (weight percent) and 63% (volume percent). The composite material complies with the requirements of DIN EN ISO 4049. Application range: Universal dental restorative material for the following indications: - cavity classes I to V - inlays, veneers (direct and indirect) - crown suprastructures - post and core buildups
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    K Number
    K052781
    Device Name
    BREFORMANCE
    Date Cleared
    2005-12-09

    (67 days)

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

    BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bredent Breformance is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
    Device Description
    breformance ColdCuringPolymer is a C+B material for temporary restorations
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    K Number
    K020427
    Device Name
    AB BELT
    Manufacturer
    Date Cleared
    2002-09-13

    (217 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE DEZAC GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ab Belt device is indicated for use for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.
    Device Description
    The Ab Belt is a single channel battery operated muscle stimulation system specifically designed for improving abdominal muscle tone, for strengthening the abdominal muscles and for developing a firmer abdomen. It comprises an electronic stimulation controller module which generates the required electrical stimulation signals and an abdominally worn electrode belt which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt. The device is supplied with a set of three identical electrodes, a tube of conductive gel, an instruction manual, a set of batteries and a fabric belt extension for fuller figures. Power is derived from three (3) 1.5V AAA batteries located on an external pop-on connector and slid into a pocket on the belt facia. The central umbilical electrode is common to each of the left and right stimulation circuits. The electrodes connect mechanically to 'press-studs' mounted on the inner face of the abdominal belt. The studs are presented in such a way that each of the outer electrodes may be rotated about a single common stud to accommodate both inner and outer muscle groups. Only these single common studs of the outer electrodes and the central umbilical electrode are electrically connected to the stimulator unit. This prevents stimulation to the user through a stud, which is not covered by an electrode pad. The user extends the belt and puts it in a wrapping motion from front to back, closing it at the back using Velcro patches. When the belt is in place the central electrode locates over the umbilicus and the two outer electrodes locate on either side of the body towards the mid axillary line, between the pelvis and the rib cage. It is well known in the art that this electrode positioning is particularly useful for stimulating the abdominal muscles. The pulsed stimulation current passes between the outer and center electrodes only. There is no current passed from outer electrode to outer electrode. The user has no access to the wiring or connectors as they are stored internally within the belt structure. As a result he or she cannot alter the current path and so the possibilities for misuse are greatly reduced.
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    K Number
    K020429
    Device Name
    AB BELT PRO
    Manufacturer
    Date Cleared
    2002-09-13

    (217 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE DEZAC GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ab Belt Pro device is indicated for use for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.
    Device Description
    The Ab Belt Pro is a single channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles for the purposes of improving abdominal muscle tone, strengthening the abdominal muscles and developing a firmer abdomen. It comprises an electronic stimulation controller module which generates the required electrical stimulation signals and an abdominally worn electrode belt which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt.
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    K Number
    K022006
    Device Name
    CONDUCTIVE GEL
    Manufacturer
    Date Cleared
    2002-09-13

    (86 days)

    Product Code
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE DEZAC GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulators) and EMS (electrical muscle stimulators). The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
    Device Description
    The Conductive Gel is a colored gel used for reducing the impedance between electrodes and the skin. The gel is to be generously applied to the area under an electrode, which is to be used. The gel can be washed off the skin after use.
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    K Number
    K001337
    Device Name
    DANIELS SHARPSMART REUSABLE SHARPS CONTAINER
    Manufacturer
    Date Cleared
    2000-07-05

    (69 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE DANIELS CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K981997
    Device Name
    POSI-STOP/POSI-TRAC SYSTEM
    Date Cleared
    1999-01-12

    (218 days)

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

    THE DENTAL MEDICAL DEVICE CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Posi-Stop/Posi-Trac System consists of 12 drills plus a starter drill utilized in osteotomy procedures before implant insertion. The Posi-Stop/Posi-Trac System is designed for use with or without a surgical guide. The system allows the dental practitioner to increase size gradations in 0.5mm steps for final sizing for implant type customization. The system is truly generic in that its 0.5mm size gradations allows the doctor to switch to a final sizing drill for implant type customization.
    Device Description
    The Posi-Stop/Posi-Trac System consists of 12 drills plus a starter drill utilized in osteotomy procedures before implant insertion. The system is designed for use with or without a surgical guide and allows for size gradations in 0.5mm steps for final sizing for implant type customization. The system includes a 1.6mm starter drill, Posi-Trac drills, and Posi-Stop instruments. The 1.6mm drill is the only depth cutting instrument, while the remaining drills cut only on the outer 0.5mm to prevent excessive depth penetration. The Posi-Trac drill has a pilot end of 1.6mm and is used to widen the osteotomy. The Posi-Stop instrument is utilized until the correct width is achieved. The Posi-Stop can be adjusted along a track guide. The 2.0 - 4.5mm sizes are safety ended.
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    K Number
    K980443
    Device Name
    PEAK FLOW METER MINIMAX
    Manufacturer
    Date Cleared
    1998-04-30

    (84 days)

    Product Code
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE D&T, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    "MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR) for the evaluation of lung function of persons with asthma.
    Device Description
    "MINIMAX" Peak Flow Meter is a portable device for measurement of peak expiratory flow rate (PEFR)
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