510(k) K020391

STERN MICRO ERA ATTACHMENT SYSTEM by Sterngold — Product Code DZE

K020391 is an FDA 510(k) premarket notification submitted by Sterngold for the device "STERN MICRO ERA ATTACHMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 8, 2002. 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.