Product code JEX— Dental

FDA has cleared 7 devices under product code JEX between 1976 and 1995, 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.

• 19951 clearance
• 19941 clearance
• 19922 clearances
• 19851 clearance
• 19841 clearance
• 19761 clearance

• Unitek Corp.3 clearances
• Unitex Corp.1 clearance
• Sybron Dental Specialties, Inc.1 clearance
• Dentauraum, Inc.1 clearance
• Adp Intl., Inc.1 clearance

• K955242 — TITANIUM BIRD BEAK PLIERSybron Dental Specialties, Inc.·1995-12-01
• K935141 — DENTAURUM PLIERSDentauraum, Inc.·1994-01-31
• K924645 — TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSUnitek Corp.·1992-11-25
• K924295 — DEBRACKETING INSTRUMENTUnitek Corp.·1992-11-23
• K854088 — UNITEK LIFT-OFF DEBRACKETING INSTRUMENTUnitex Corp.·1985-11-26
• K843742 — UNITEK CONVERTIBLE CAP REMOVER TOOLUnitek Corp.·1984-11-09
• K760984 — ORTHODONTIC INSTRUMENTSAdp Intl., Inc.·1976-11-15