Product code EKB— Dental

FDA has cleared 3 devices under product code EKB between 1982 and 1985, filed by 3 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.

• 19851 clearance
• 19831 clearance
• 19821 clearance

• Treace Medical, Inc.1 clearance
• Pacific Dental Corp.1 clearance
• Artiberia1 clearance

• K851724 — 1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERSArtiberia·1985-07-02
• K823914 — EXPLORER TIPTreace Medical, Inc.·1983-01-21
• K821780 — BEACH EXPLORER NO. 23T.G.Pacific Dental Corp.·1982-07-06