FDA 510(k)

Neodent Implant System - Helix Short Implant System

K-Number: K223638 · 2023-06-23

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.

Decision Date2023-06-23

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - Helix Short Implant System is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2023-06-23 under approval number K223638. 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 - Helix Short Implant System?

Neodent Implant System - Helix Short Implant System is a medical device that received FDA 510(k) clearance on 2023-06-23. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K223638.

When was Neodent Implant System - Helix Short Implant System approved by the FDA?

Neodent Implant System - Helix Short Implant System received FDA 510(k) clearance on 2023-06-23, under approval number K223638.

What company makes Neodent Implant System - Helix Short Implant System?

Neodent Implant System - Helix Short Implant System is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A..

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

The FDA product code for Neodent Implant System - Helix Short Implant System is DZE.

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Related PubMed Literature

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Related Devices (Code: 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.