Product code EKW— Dental

FDA has cleared 7 devices under product code EKW between 1976 and 1987, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19872 clearances
• 19861 clearance
• 19831 clearance
• 19821 clearance
• 19801 clearance
• 19761 clearance

• Walter Lorenz Surgical, Inc.1 clearance
• Union Broach, Div. Moyco Industries, Inc.1 clearance
• Union Branch1 clearance
• Treace Medical, Inc.1 clearance
• Ipco Corp.1 clearance
• Advanced Medical, Inc.1 clearance
• Adp Intl., Inc.1 clearance

• K871493 — DENTI-TRAY(TM)Advanced Medical, Inc.·1987-06-24
• K870765 — CANNULATED INSTRUMENT CLEANERSTreace Medical, Inc.·1987-05-27
• K862523 — MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYSWalter Lorenz Surgical, Inc.·1986-08-01
• K831749 — ENDODONTIC BROACH(76EKN) BARBED BROACHUnion Branch·1983-07-12
• K823489 — ENDODONTIC BROACH-BARBED BROACHUnion Broach, Div. Moyco Industries, Inc.·1982-12-15
• K800292 — ENDEX BROACH, ENDODONTICIpco Corp.·1980-02-19
• K760985 — HAND INSTRUMENTSAdp Intl., Inc.·1976-11-15