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

EMB — Predicate Candidate Screening

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

49 daysmedian FDA review time

145 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K161630	Provicol QM Plus	Voco GmbH	2016-09-15	94
K120695	DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE	Dentist IN A Box Pty., Ltd.	2012-06-12	97
K110759	TEMPOCEM	Dmg USA, Inc.	2011-06-10	84
K073539	PROVISA CEM	Cavex Holland BV	2008-01-31	45
K020158	NON-EUGENOL TEMPORARY CEMENT	J. Morita USA, Inc.	2002-03-07	49
K941066	DENTAL 911	L.A.F. Industries, Inc.	1995-05-24	442
K861681	DENTIMEDIC DENTAL EMERGENCY KIT	Dentimedic	1986-09-23	145
K862745	EUGENOL USP	E&D Dental Manufacturing Co.	1986-07-31	10
K821581	DEN TEMP	Majestic Drug Co., Inc.	1982-06-14	17
K801779	OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT	Oxy Dental Products, Inc.	1980-08-07	10
K772315	KWIKAP	Den-Mat Corp.	1978-01-03	15

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