510(k) K023580

STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM by Sterngold — Product Code DZE

K023580 is an FDA 510(k) premarket notification submitted by Sterngold for the device "STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on January 17, 2003. 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.