Neodent Implant System - GM Zygomatic Implant System
K-Number: K232099 · 2023-10-31
Decision Date2023-10-31
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Neodent Implant System - GM Zygomatic Implant System is a medical device manufactured by JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2023-10-31 under approval number K232099. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neodent Implant System - GM Zygomatic Implant System?
Neodent Implant System - GM Zygomatic Implant System is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K232099.
When was Neodent Implant System - GM Zygomatic Implant System approved by the FDA?
Neodent Implant System - GM Zygomatic Implant System received FDA 510(k) clearance on 2023-10-31, under approval number K232099.
What company makes Neodent Implant System - GM Zygomatic Implant System?
Neodent Implant System - GM Zygomatic Implant System is manufactured by JJGC Indústria e Comércio de Materiais Dentários S.A..
What is the FDA product code for Neodent Implant System - GM Zygomatic Implant System?
The FDA product code for Neodent Implant System - GM Zygomatic Implant System is DZE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.