510(k) K913348

THE STERN ERA SYSTEM by Sterngold/Implamed — Product Code DZE

K913348 is an FDA 510(k) premarket notification submitted by Sterngold/Implamed for the device "THE STERN ERA SYSTEM". The FDA issued a decision of Substantially Equivalent on January 30, 1992. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sterngold/Implamed has at least 10 other 510(k) clearances on record.