510(k) K232099

Neodent Implant System - GM Zygomatic Implant System by JJGC Indústria e Comércio de Materiais Dentários S.A. — Product Code DZE

K232099 is an FDA 510(k) premarket notification submitted by JJGC Indústria e Comércio de Materiais Dentários S.A. for the device "Neodent Implant System - GM Zygomatic Implant System". The FDA issued a decision of Substantially Equivalent on October 31, 2023. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. JJGC Indústria e Comércio de Materiais Dentários S.A. has at least 10 other 510(k) clearances on record.