Atlas FDA

LCN

31 FDA 510(k) clearances · Product code

70 daysmedian time to decision
116 days90th percentile
31clearances measured

FDA profile

Official device name
Scraper, Tongue
Device class
Class I (low risk)
Regulation
21 CFR 872.6855
Medical specialty
Dental
Flags
GMP exempt
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RecordFirmDate
MIRACLEBREATH TONGUE CLEANER (K992270)Stellar Labs, Inc.1999-09-23
ORALGIENE TONGUE CLEANER (K990344)Oralgiene USA, Inc.1999-05-04
UNIK TONGUE CLEANER (K983683)Unik Products, Inc.1999-01-14
BREATHTIQUE TONGUE SCRAPER (K983087)Custom Medical Arts, Inc.1998-11-18
BREATHAID TONGUE SCRAPER (K981808)Breathaid, LLC1998-08-11
COPPER TONGUE SCRAPER (K980842)Ontel Products Corp.1998-05-20
CYBERSONIC (K980075)American Dentronics, Inc.1998-03-04
ENFRESH TONGUE BRUSH (K973424)Enfresh Products, LLC1997-12-09
TONGUE KLEAN (K973175)Softek Ent.1997-10-14
BREATH-SO-FRESH TONGUE CLEANER (K972644)Intl. Dental Design Specialists, Inc.1997-09-11
BREATH ACE BREATHFRESHENER (K972131)Beyond 21st Century, Inc.1997-07-18
BREATH TAKER (K971887)Hofa, LLC1997-06-10
AYURVEDIC TONGUE CLEANER (K971025)Calello Martinez P.C.1997-05-22
OOLI-U(TONGUE SCRAPER) (K970042)Telefax Intl.1997-03-14
OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE (K962941)Deep Trading Corp.1996-10-08
TONGUE SCRAPPER (K961574)U.S. Dentek Corp.1996-06-10
TONGUE CLEANER (K961660)Jack Conrey1996-05-31
TONGUE CLEAN (K952446)1-800-Tongues, Inc.1995-06-22
TONGUE SCRAPER (K942076)Maharishi Ayur-Ved1994-08-23
A MANO TONGUE CLEANSER (K932839)A Mano Products, Ltd.1993-09-23
SYB, OR SAVE YOUR BREATH TONGUE CLEANER (K902164)P.J., Inc.1990-10-12
THE TONGUE BRUSH (K901408)Garry Laboratories, Inc.1990-05-21
THE TONGUE CLEANER (K892388)Rajiv R. Shah1989-06-16
COAT-A-COUNT PCP KIT NUMBER TKPC1 (K870875)Diagnostic Products Corp.1987-03-19
T-SWIPE -TONGUE CLEANER (K851006)Kumar Ent.1985-05-21
MEDI-TECH DILATATION CATHETERS (K844292)Medi-Tech, Inc.1984-11-23
ARK TONGUE CLEANER (K844291)Arkay Co.1984-11-23
ARK TONGUE CLEANER (K841077)Arkay Co.1984-07-02
SILVERAK (K833838)Anil S. Gautam1984-03-02
TONGUE CLEANER (K810149)Agp, Inc.1981-02-05
TONGUE SCRAPER (K790895)Peter G. Finamore, Sr.1979-09-04

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