Atlas FDA

EKW

7 FDA 510(k) clearances · Product code

30 daysmedian time to decision
90 days90th percentile
7clearances measured

FDA profile

Official device name
Broach, Endodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Medical specialty
Dental
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RecordFirmDate
DENTI-TRAY(TM) (K871493)Advanced Medical, Inc.1987-06-24
CANNULATED INSTRUMENT CLEANERS (K870765)Treace Medical, Inc.1987-05-27
MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS (K862523)Walter Lorenz Surgical, Inc.1986-08-01
ENDODONTIC BROACH(76EKN) BARBED BROACH (K831749)Union Branch1983-07-12
ENDODONTIC BROACH-BARBED BROACH (K823489)Union Broach, Div. Moyco Industries, Inc.1982-12-15
ENDEX BROACH, ENDODONTIC (K800292)Ipco Corp.1980-02-19
HAND INSTRUMENTS (K760985)Adp Intl., Inc.1976-11-15

Track EKW automatically

Every clearance here is in the API, with alerts when new ones post.