Product code EJB— Dental

FDA has cleared 8 devices under product code EJB between 1983 and 2014, filed by 8 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.

• 20141 clearance
• 20031 clearance
• 19981 clearance
• 19931 clearance
• 19921 clearance
• 19871 clearance
• 19832 clearances

• Treace Medical, Inc.1 clearance
• Neks Technologies1 clearance
• Military Engineering, Inc.1 clearance
• Lone Star Technologies1 clearance
• Joel Lander D.D.S.1 clearance
• E&D Dental Products, Inc.1 clearance
• Centrix, Inc.1 clearance
• Aukland Medical Plastics, Inc.1 clearance

• K140144 — BENDA WEDGECentrix, Inc.·2014-07-08
• K023367 — DETECTAR, MODEL N123-MINeks Technologies·2003-06-25
• K981234 — FLARE,FILE, FILLLone Star Technologies·1998-06-05
• K930094 — AUKUSLEEVEAukland Medical Plastics, Inc.·1993-10-20
• K922633 — CAVI-ZYMEE&D Dental Products, Inc.·1992-08-06
• K871818 — SPATULA, DENTAL, CEMENTMilitary Engineering, Inc.·1987-07-02
• K833338 — TOOTH SLOOTHJoel Lander D.D.S.·1983-11-25
• K823913 — SOFT GRIP UNI-HANDLETreace Medical, Inc.·1983-01-26