510(k) K101225

PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 by Promimic AB — Product Code DZE

K101225 is an FDA 510(k) premarket notification submitted by Promimic AB for the device "PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1". The FDA issued a decision of Substantially Equivalent on January 25, 2011. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Promimic AB has at least 1 other 510(k) clearance on record.