510(k) K182865

Neodent Instruments Kits by Jjgc Industria E Comercio DE Materiais Dentarios S.A. — Product Code KCT

K182865 is an FDA 510(k) premarket notification submitted by Jjgc Industria E Comercio DE Materiais Dentarios S.A. for the device "Neodent Instruments Kits". The FDA issued a decision of Substantially Equivalent on May 7, 2019. 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 Industria E Comercio DE Materiais Dentarios S.A. has 27 other 510(k) clearances on record.