510(k) K946198

IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR by Sterngold — Product Code DZE

K946198 is an FDA 510(k) premarket notification submitted by Sterngold for the device "IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR". The FDA issued a decision of Substantially Equivalent on June 14, 1995. 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.