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510(k) Data Aggregation

    K Number
    K992270
    Device Name
    MIRACLEBREATH TONGUE CLEANER
    Manufacturer
    STELLAR LABS, INC.
    Date Cleared
    1999-09-23

    (79 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove plaque and food debris from the surface of the tongue and to help fight bad breath and promote oral hygiene.
    Device Description
    The device is a natural polypropylene band. It is formed into a u-shape by holding each end with the finger tips. The device is then placed on the back of the tongue and pulled forward gently with either the flat or rippled edge down. There are no sharp edges on the device.
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    K Number
    K990344
    Device Name
    ORALGIENE TONGUE CLEANER
    Manufacturer
    ORALGIENE USA, INC.
    Date Cleared
    1999-05-04

    (89 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.
    Device Description
    The Oralgiene Tongue Cleaner is a "T" shaped manual device used in the same manner as other items already in the marketplace. It is all in one piece and has mild ridges, but no sharp edges. It is composed of a durable and safe plastic.
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    K Number
    K983683
    Device Name
    UNIK TONGUE CLEANER
    Manufacturer
    UNIK PRODUCTS, INC.
    Date Cleared
    1999-01-14

    (86 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene.
    Device Description
    This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a toothbrush, and a U-shaped loop end made of either polypropylene plastic or stainless steel. The device is used by placing the loop end at the back of the tongue and gently dragging it toward the front. The device is designed so that there are no sharp edges.
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    K Number
    K983087
    Device Name
    BREATHTIQUE TONGUE SCRAPER
    Manufacturer
    CUSTOM MEDICAL ARTS, INC.
    Date Cleared
    1998-11-18

    (76 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Breathtique Tongue Scraper is intended to be used to remove bacterial plaque and food debris from the surface of the tongue.
    Device Description
    Not Found
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    K Number
    K981808
    Device Name
    BREATHAID TONGUE SCRAPER
    Manufacturer
    BREATHAID, LLC.
    Date Cleared
    1998-08-11

    (82 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K980842
    Device Name
    COPPER TONGUE SCRAPER
    Manufacturer
    ONTEL PRODUCTS CORP.
    Date Cleared
    1998-05-20

    (77 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good oral hygiene. It is intended for over-the-counter point of sale as are other predicate devices.
    Device Description
    This device is a U-formed design made of Copper.
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    K Number
    K980075
    Device Name
    CYBERSONIC
    Manufacturer
    AMERICAN DENTRONICS, INC.
    Date Cleared
    1998-03-04

    (55 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use to remove surface tongue debris, residue, plaque or filmy build-up that result from eating, drinking, smoking or other types of consumption which can lead to bad breath. Also may be used to remove salivary tongue plaques and residue that naturally accumulate during sleep or between cleanings.
    Device Description
    Not Found
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    K Number
    K973424
    Device Name
    ENFRESH TONGUE BRUSH
    Manufacturer
    ENFRESH PRODUCTS LLC.
    Date Cleared
    1997-12-09

    (90 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove plaque and food debris from the surface of the tongue.
    Device Description
    The Enfresh Tongue Brush and the predicate tongue brushes, tongue scrapers, and tongue cleaners have very similar principles of operation. They are all manual devices that are used by applying a brushing, scraping, or both brushing and scraping motion to the surface of the tongue to remove plaque and food debris from the surface of the tongue. The handle and the bristles of the Enfresh Tongue Brush and Garry Laboratories's The Tongue Brush are composed of plastic, rubber, and nylon, while Telefax International's OOLI-U (Tongue Scraper) is composed of stainless steel.
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    K Number
    K973175
    Device Name
    TONGUE KLEAN
    Manufacturer
    SOFTEK ENT.
    Date Cleared
    1997-10-14

    (50 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TONGUE KILEAN IS INDICATED AS PART OF THE ORAL HYSIENE DALLY TO REMOVE PLAQUE FROM THE SURFACE Of THE TONGUE
    Device Description
    Softek's Tongue Klean is a simple device which is used to scrape build up of plaque from the surface of the tongue. Tongue Klean is easy to use and does not present any undue risk to the user of Tongue Klean.
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    K Number
    K972644
    Device Name
    BREATH-SO-FRESH TONGUE CLEANER
    Manufacturer
    INTL. DENTAL DESIGN SPECIALISTS, INC.
    Date Cleared
    1997-09-11

    (58 days)

    Product Code
    LCN, ICN
    Regulation Number
    872.6855
    Why did this record match?
    Product Code :

    LCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.
    Device Description
    The Breath-So-Fresh tongue cleaner is molded to a modified "spoon-shape". One end of the tongue cleaner is a handle. The other end is shaped as the bowl of the spoon. The tongue cleaner is held as a spoon, except upside down. The end tip of the spoon end is mildly rippled but has no sharp edges. The total length of the Breath-So-Fresh tongue cleaner is seven inches long and the cleaner is one and one-fourth inches wide at the widest portion. The Breath-So-Fresh tongue cleaner is composed of a hard white plastic, either a polycarbonate plastic or a plastic similar to polycarbonate. This plastic is flexible as well as durable and is well suited to dental applications. The tongue cleaner is designed so that there are no sharp edges to the plastic.
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