Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K182017
    Device Name
    Compex HD
    Manufacturer
    AdDent, Inc.
    Date Cleared
    2019-04-29

    (276 days)

    Product Code
    QGO, EBZ, EEG, OGO
    Regulation Number
    872.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    AdDent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compex HD is intended to be used by a dentist or health care provider to warm and dispense dental composite materials contained in a compule or PLT (Pre Loaded Tip) to 155 degrees F (68 degrees C).
    Device Description
    The Compex HD uses a heating device to elevate the temperature of dental composite material contained in a compule (PLT) to allow it to flow and be easily extruded. It utilizes a plastic housing in the shape of a traditional dispensing qun. The housing contains a heater element(s) and/or an electrically conductive plastic compule that itself acts as a heater when a current is applied. A control circuit board assembly and rechargeable lithium lon battery are used to apply power to the heater. A separate wall plug-in USB power supply is used to charge the battery. The unit will not function with the USB power supply connected to the unit.
    Ask a Question
    K Number
    K121282
    Device Name
    MICROLUX/DL MICROLUX/BLU BIO/SCREEN
    Manufacturer
    ADDENT, INC.
    Date Cleared
    2012-07-24

    (85 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADDENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist as an adjunct to traditional oral examination by incandescent light, combined with further examination with one of three oral examination lights manufactured by AdDent, Inc. The Microlux DL (K041614), Microlux BLU (K072309), and Bio/Screen (K082668). The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.
    Device Description
    The ORABLU Oral Lesion Marking System is a three component swab system.
    Ask a Question
    K Number
    K082668
    Device Name
    BIO-SCREEN
    Manufacturer
    ADDENT, INC.
    Date Cleared
    2009-01-23

    (133 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADDENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bio-Screen is intended to be used by a dentist or health care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities and aid in defining lesion borders
    Device Description
    This device uses an array of short wave blue LED's in the technique of biofluorescence to demonstrate abnormal oral tissue It employs a built in optical filter to improve contrast between healthy and abnormal tissue and improve visualization
    Ask a Question
    K Number
    K072309
    Device Name
    MICROLUX/BLU
    Manufacturer
    ADDENT, INC.
    Date Cleared
    2007-11-19

    (94 days)

    Product Code
    EAZ
    Regulation Number
    872.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADDENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K062961
    Device Name
    MICROLUX TRANSILLUMINATOR
    Manufacturer
    ADDENT, INC.
    Date Cleared
    2007-02-08

    (132 days)

    Product Code
    NTK
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADDENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microlux Transilluminator is a device used upon initial examination of the dental patient to help locate crown fractures, posterior and anterior caries. The Microlux Transilluminator is a screening device used to help locate caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.
    Device Description
    The Microlux Transilluminator consists of a battery powered, high output L.E.D. light source, (three 'N" size batteries are included) and a fiber-optic glass light guide with either a 3mm or 2mm tip. The fiber-optic glass light guide snaps into the light source. The fiber-optic light guide is autoclaveable. The light source can be wiped with disinfectant. Disposable custom fitted sleeves are also available the cover the entire unit to prevent cross contamination.
    Ask a Question
    K Number
    K061395
    Device Name
    CALSET COMPOSITE HEATER
    Manufacturer
    ADDENT, INC.
    Date Cleared
    2006-06-23

    (35 days)

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

    ADDENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The Calset unit is used to warm dental composite materials and whitening bleach to130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).
    Device Description
    The Calset is a warming device used to heat dental materials prior to their use in the mouth. It consists of a base unit that contains a heating element a temperature control circuit with LED indicators, a removable metal tray that is designed to hold different materials and a low voltage wall transformer that provides power to the unit.
    Ask a Question
    K Number
    K041614
    Device Name
    MICROLUX DL
    Manufacturer
    ADDENT, INC.
    Date Cleared
    2005-04-04

    (293 days)

    Product Code
    EAZ
    Regulation Number
    872.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADDENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.
    Device Description
    The Microlux/DL is used to enhance dental examination of lesions of the oral mucosa. The device consists of a battery powered light source that uses a blue-white LED, a rigid diffused fiber optic light guide. It is used in conjunction with a non-toxic dilute (1%) acetic acid rinse for the viewing of oral lesions. The fiber optic illuminator itself is non-tissue contacting, and is classified as a 510(k) Exempt FDA Device.
    Ask a Question

    Page 1 of 1