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

EFD — Predicate Candidate Screening

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

49 daysmedian FDA review time

84 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K991913	PENTAMIX 2	Espe Dental AG	1999-07-26	49
K923974	SILIMAT PLUS	Ivoclar North America, Inc.	1992-10-06	60
K922203	IPT CAPSULE MIXER	Ipt Technologies, Inc.	1992-06-03	23
K915847	AUTOMIX DENTAL AMALGAMATOR	Kerr Corporation (Danbury)	1992-03-02	67
K914340	DUOMAT 3 AMALGAMATOR	Degussa AG	1991-11-13	47
K914341	MIXOMAT AMALGAMATOR	Degussa AG	1991-11-13	47
K914339	DENTOMAT 3 AMALGAMATORS	Degussa AG	1991-11-07	41
K910632	ACCU-MIX AMALGAMATOR	Wykle Research, Inc.	1991-03-15	30
K901909	SILAMAT (AMALGAMATOR)	Ivoclar North America, Inc.	1990-06-22	56
K891612	DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.	Implant Innovations International, Inc.	1989-06-12	84
K891064	ESPE CAPMIX	Espe GmbH (Us)	1989-05-30	90
K880993	AMALGAMATOR	Acecodent, Inc.	1988-05-11	64
K791410	AMALGAMATOR MODEL SDC--	Sierra Laboratories, Inc.	1979-09-19	69
K780560	DENTAL AMALGAMATOR	L.D. Caulk Co.	1978-04-21	16
K771901	CAPMIX	Espe Dental Products	1977-10-20	13

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