FDA 510(k) Applications for Medical Device Product Code "LCN"
(Scraper, Tongue)

FDA 510(k) Number Applicant Device Name Decision Date
K980075 AMERICAN DENTRONICS, INC. CYBERSONIC 03/04/1998
K972131 BEYOND 21ST CENTURY, INC. BREATH ACE BREATHFRESHENER 07/18/1997
K981808 BREATHAID, LLC. BREATHAID TONGUE SCRAPER 08/11/1998
K971025 CALELLO MARTINEZ P.C. AYURVEDIC TONGUE CLEANER 05/22/1997
K983087 CUSTOM MEDICAL ARTS, INC. BREATHTIQUE TONGUE SCRAPER 11/18/1998
K962941 DEEP TRADING CORP. OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE 10/08/1996
K973424 ENFRESH PRODUCTS LLC. ENFRESH TONGUE BRUSH 12/09/1997
K971887 HOFA LLC. BREATH TAKER 06/10/1997
K972644 INTL. DENTAL DESIGN SPECIALISTS, INC. BREATH-SO-FRESH TONGUE CLEANER 09/11/1997
K961660 JACK CONREY TONGUE CLEANER 05/31/1996
K980842 ONTEL PRODUCTS CORP. COPPER TONGUE SCRAPER 05/20/1998
K990344 ORALGIENE USA, INC. ORALGIENE TONGUE CLEANER 05/04/1999
K973175 SOFTEK ENT. TONGUE KLEAN 10/14/1997
K992270 STELLAR LABS, INC. MIRACLEBREATH TONGUE CLEANER 09/23/1999
K970042 TELEFAX INTL. OOLI-U(TONGUE SCRAPER) 03/14/1997
K961574 U.S. DENTEK CORP. TONGUE SCRAPPER 06/10/1996
K983683 UNIK PRODUCTS, INC. UNIK TONGUE CLEANER 01/14/1999


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