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

JET — Predicate Candidate Screening

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

34 daysmedian FDA review time

196 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K963747	REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS	Whitehill Manufacturing, Inc.	1996-12-16	90
K942633	ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE	Oral-B Laboratories	1995-04-27	328
K930178	ELECTRO FLOSS	Arizona Implant Dentistry	1993-07-28	196
K911418	GUM MASSAGER	Burn-Henderson Partnership	1991-07-17	107
K885189	MASSAGING PICK FOR ORAL HYGIENE	Dentek Corp.	1989-03-17	91
K890910	PLAKOF	Ximex, Ltd.	1989-03-16	21
K883225	FLOSSIE	Richard G. Deniro	1988-08-30	29
K881900	PERMA-PIC PLASTIC TOOTHPICK	The Perma-Pic Co.	1988-06-01	26
K881046	SUPER PIK MASSAGING PICK FOR ORAL HYGIENE	U.S. Dentek Corp.	1988-05-13	63
K860779	ULTRAPROX, INTERPROXIMAL TOOTHBRUSH	William J. Forni, D.D.S.	1986-04-02	30
K850775	DENTAL MASSAGING PICKS	L.A.K. Ent., Inc.	1985-04-10	43
K844238	ORAPIK PERIODONTAL SCALER	Dental Concepts, LLC	1984-12-03	32
K832949	SANODENT DOUBLE-ENDED INTERDENTAL CLEAN	Coopercare, Inc.	1983-10-04	32
K821629	FIXIDENT	Moyco Industries, Inc.	1982-06-14	12
K820979	RESILIENT GUM EXERCISER	Martin A. Hass, D.D.S.	1982-05-10	34

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