510(k) K192221

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts by Implant Direct Sybron Manufacturing, LLC — Product Code DZE

K192221 is an FDA 510(k) premarket notification submitted by Implant Direct Sybron Manufacturing, LLC for the device "Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts". The FDA issued a decision of Substantially Equivalent on June 25, 2020. 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.