510(k) K041271

STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM by Sterngold — Product Code DZE

K041271 is an FDA 510(k) premarket notification submitted by Sterngold for the device "STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 28, 2004. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sterngold has at least 10 other 510(k) clearances on record.