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Found 17 results
510(k) Data Aggregation
K Number
K992270Device Name
MIRACLEBREATH TONGUE CLEANER
Manufacturer
STELLAR LABS, INC.
Date Cleared
1999-09-23
(79 days)
Product Code
LCN
Regulation Number
872.6855Why 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
K990344Device Name
ORALGIENE TONGUE CLEANER
Manufacturer
ORALGIENE USA, INC.
Date Cleared
1999-05-04
(89 days)
Product Code
LCN
Regulation Number
872.6855Why 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
K983683Device Name
UNIK TONGUE CLEANER
Manufacturer
UNIK PRODUCTS, INC.
Date Cleared
1999-01-14
(86 days)
Product Code
LCN
Regulation Number
872.6855Why 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
K983087Device Name
BREATHTIQUE TONGUE SCRAPER
Manufacturer
CUSTOM MEDICAL ARTS, INC.
Date Cleared
1998-11-18
(76 days)
Product Code
LCN
Regulation Number
872.6855Why 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
K981808Device Name
BREATHAID TONGUE SCRAPER
Manufacturer
BREATHAID, LLC.
Date Cleared
1998-08-11
(82 days)
Product Code
LCN
Regulation Number
872.6855Why 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
K980842Device Name
COPPER TONGUE SCRAPER
Manufacturer
ONTEL PRODUCTS CORP.
Date Cleared
1998-05-20
(77 days)
Product Code
LCN
Regulation Number
872.6855Why 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
K980075Device Name
CYBERSONIC
Manufacturer
AMERICAN DENTRONICS, INC.
Date Cleared
1998-03-04
(55 days)
Product Code
LCN
Regulation Number
872.6855Why 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
K973424Device Name
ENFRESH TONGUE BRUSH
Manufacturer
ENFRESH PRODUCTS LLC.
Date Cleared
1997-12-09
(90 days)
Product Code
LCN
Regulation Number
872.6855Why 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
K973175Device Name
TONGUE KLEAN
Manufacturer
SOFTEK ENT.
Date Cleared
1997-10-14
(50 days)
Product Code
LCN
Regulation Number
872.6855Why 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
K972644Device 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
872.6855Why 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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