510(k) K214051

Neodent Implant System-Helix NGM Compact Surgical Kit Cases by JJGC Indústria e Comércio de Materiais Dentários S.A. — Product Code KCT

K214051 is an FDA 510(k) premarket notification submitted by JJGC Indústria e Comércio de Materiais Dentários S.A. for the device "Neodent Implant System-Helix NGM Compact Surgical Kit Cases". The FDA issued a decision of Substantially Equivalent on April 13, 2022. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. JJGC Indústria e Comércio de Materiais Dentários S.A. has at least 10 other 510(k) clearances on record.