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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
ENFRESH PRODUCTS LLC.
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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