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

EEG — Predicate Candidate Screening

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

128 daysmedian FDA review time

249 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K122725	TANDA PEARL, ULTRAWYTE, PEARL	Syneron Beauty	2012-11-27	83
K110888	ABSOLUTE WHITE LIGHT	Dr. Fresh, Inc.	2012-01-12	288
K063704	BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101	Beks Incorporated	2007-02-20	69
K052040	QUICKSMILE	Cosmetic Dental Materials, Inc.	2005-10-18	82
K042153	SOUTH BEACH SMILE LIGHT WHITENING SYSTEM	Dentovations, Inc.	2004-11-08	91
K041392	SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC,	CAO Group, Inc.	2004-11-08	167
K895174	UNION BROACH BLEACHING LIGHT	Union Broach, Div. Moyco Industries, Inc.	1990-04-13	249
K884937	BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING	Grass-Telefactor Product Group	1989-04-14	137
K862385	SCHEIN BLEACHING UNIT	Henry Schein, Inc.	1986-10-30	128
K854692	MONARCH II BLEACHING INSTRUMENT	Almore Intl., Inc.	1986-05-12	172
K832179	HOT PROBE MODEL 6001	Analytic Technology	1983-10-04	90
K790378	REYNOLDS BLEACHING PROCESS	Reynolds Laboratories	1979-04-10	46

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