Product code ELY— Dental

FDA has cleared 4 devices under product code ELY between 1990 and 2010, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20101 clearance
• 19981 clearance
• 19921 clearance
• 19901 clearance

• National Health-Care Equipment, Inc.1 clearance
• Dmg USA, Inc.1 clearance
• Degussa AG1 clearance
• Aleaciones Dentales Zeyco, S.A. DE C.V.1 clearance

• K093587 — DENTAL MERCURYDmg USA, Inc.·2010-01-21
• K973548 — MERCURY DENTALAleaciones Dentales Zeyco, S.A. DE C.V.·1998-03-23
• K913814 — MODEL #05 ANEROID SPHYGMOMANOMETER KITNational Health-Care Equipment, Inc.·1992-01-16
• K902388 — DENTAL-QUECKSILBER (DENTAL MERCURY)Degussa AG·1990-06-28