Product code ELA— Dental

FDA has cleared 4 devices under product code ELA between 1980 and 1995, filed by 4 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
• 19861 clearance
• 19821 clearance
• 19801 clearance

• Travenol Laboratories, S.A.1 clearance
• Miltex, Inc.1 clearance
• Ela Medical, Inc.1 clearance
• Analytic Technology1 clearance

• K952363 — OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)Ela Medical, Inc.·1995-08-15
• K854168 — TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTESTravenol Laboratories, S.A.·1986-03-13
• K823326 — DENTAL INSTRUMENTS - CUTTING INSTRUMENTMiltex, Inc.·1982-11-24
• K801974 — ANALYTIC TECH. METAL POINT HEATER #3001Analytic Technology·1980-11-12