510(k) K201225

Neodent Implant System - GM Helix Implants 7.0 by Jjgc Industria E Comercio DE Materiais Dentarios S.A. — Product Code DZE

K201225 is an FDA 510(k) premarket notification submitted by Jjgc Industria E Comercio DE Materiais Dentarios S.A. for the device "Neodent Implant System - GM Helix Implants 7.0". The FDA issued a decision of Substantially Equivalent on Sep 4, 2020. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Jjgc Industria E Comercio DE Materiais Dentarios S.A. has 27 other 510(k) clearances on record.