510(k) K111798

STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... by Sterngold Dental, LLC — Product Code DZE

K111798 is an FDA 510(k) premarket notification submitted by Sterngold Dental, LLC for the device "STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ...". The FDA issued a decision of Substantially Equivalent on Jun 1, 2012. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sterngold Dental, LLC has 11 other 510(k) clearances on record.