Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LCN — Predicate Candidate Screening

31 FDA 510(k) clearances under this product code; the 50 most recent screened below.

70 daysmedian FDA review time

116 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days
K992270	MIRACLEBREATH TONGUE CLEANER	Stellar Labs, Inc.	1999-09-23	79
K990344	ORALGIENE TONGUE CLEANER	Oralgiene USA, Inc.	1999-05-04	89
K983683	UNIK TONGUE CLEANER	Unik Products, Inc.	1999-01-14	86
K983087	BREATHTIQUE TONGUE SCRAPER	Custom Medical Arts, Inc.	1998-11-18	76
K981808	BREATHAID TONGUE SCRAPER	Breathaid, LLC	1998-08-11	82
K980842	COPPER TONGUE SCRAPER	Ontel Products Corp.	1998-05-20	77
K980075	CYBERSONIC	American Dentronics, Inc.	1998-03-04	55
K973424	ENFRESH TONGUE BRUSH	Enfresh Products, LLC	1997-12-09	90
K973175	TONGUE KLEAN	Softek Ent.	1997-10-14	50
K972644	BREATH-SO-FRESH TONGUE CLEANER	Intl. Dental Design Specialists, Inc.	1997-09-11	58
K972131	BREATH ACE BREATHFRESHENER	Beyond 21st Century, Inc.	1997-07-18	42
K971887	BREATH TAKER	Hofa, LLC	1997-06-10	20
K971025	AYURVEDIC TONGUE CLEANER	Calello Martinez P.C.	1997-05-22	63
K970042	OOLI-U(TONGUE SCRAPER)	Telefax Intl.	1997-03-14	67
K962941	OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPL	Deep Trading Corp.	1996-10-08	71
K961574	TONGUE SCRAPPER	U.S. Dentek Corp.	1996-06-10	48
K961660	TONGUE CLEANER	Jack Conrey	1996-05-31	31
K952446	TONGUE CLEAN	1-800-Tongues, Inc.	1995-06-22	28
K942076	TONGUE SCRAPER	Maharishi Ayur-Ved	1994-08-23	116
K932839	A MANO TONGUE CLEANSER	A Mano Products, Ltd.	1993-09-23	104
K902164	SYB, OR SAVE YOUR BREATH TONGUE CLEANER	P.J., Inc.	1990-10-12	150
K901408	THE TONGUE BRUSH	Garry Laboratories, Inc.	1990-05-21	56
K892388	THE TONGUE CLEANER	Rajiv R. Shah	1989-06-16	70
K870875	COAT-A-COUNT PCP KIT NUMBER TKPC1	Diagnostic Products Corp.	1987-03-19	16
K851006	T-SWIPE -TONGUE CLEANER	Kumar Ent.	1985-05-21	70
K844292	MEDI-TECH DILATATION CATHETERS	Medi-Tech, Inc.	1984-11-23	18
K844291	ARK TONGUE CLEANER	Arkay Co.	1984-11-23	18
K841077	ARK TONGUE CLEANER	Arkay Co.	1984-07-02	112
K833838	SILVERAK	Anil S. Gautam	1984-03-02	120
K810149	TONGUE CLEANER	Agp, Inc.	1981-02-05	15
K790895	TONGUE SCRAPER	Peter G. Finamore, Sr.	1979-09-04	120

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda