510(k) K222211

Implant Direct Dental Implant Systems Portfolio - MR Conditional by Implant Direct Sybron Manufacturing, LLC — Product Code DZE

K222211 is an FDA 510(k) premarket notification submitted by Implant Direct Sybron Manufacturing, LLC for the device "Implant Direct Dental Implant Systems Portfolio - MR Conditional". The FDA issued a decision of Substantially Equivalent on February 2, 2023. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Implant Direct Sybron Manufacturing, LLC has at least 10 other 510(k) clearances on record.