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FDA 510(k)

Neodent Implant System - Zirconia Implant System

K-Number: K250271 · 2025-08-18

ApplicantJJGC Indústria e Comércio de Materiais Dentários S.A.
Decision Date2025-08-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - Zirconia Implant System is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2025-08-18 under 510(k) number K250271. 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 - Zirconia Implant System?

Neodent Implant System - Zirconia Implant System is a medical device that received FDA 510(k) clearance on 2025-08-18. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K250271.

When did Neodent Implant System - Zirconia Implant System receive FDA 510(k) clearance?

Neodent Implant System - Zirconia Implant System received FDA 510(k) clearance on 2025-08-18, under 510(k) number K250271.

Who is the listed applicant for Neodent Implant System - Zirconia Implant System?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Implant System - Zirconia Implant System?

The FDA product code for Neodent Implant System - Zirconia 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.

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