Product code EIK— Dental

FDA has cleared 5 devices under product code EIK between 1985 and 2002, filed by 5 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.

• 20021 clearance
• 19981 clearance
• 19901 clearance
• 19861 clearance
• 19851 clearance

• Stephen M Koral, Dmd1 clearance
• Pacific Union Dental, Inc.1 clearance
• Intl. Equipment and Supply Corp.1 clearance
• Estrad B.V.1 clearance
• Artiberia1 clearance

• K013993 — NEOCALEXStephen M Koral, Dmd·2002-02-22
• K972642 — PERIO CONTROL IIEstrad B.V.·1998-01-26
• K902653 — PDS-2000Intl. Equipment and Supply Corp.·1990-09-13
• K860817 — ROOT CANAL ORGANIZERPacific Union Dental, Inc.·1986-03-17
• K851727 — 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CAArtiberia·1985-07-02