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FDA 510(k)

Neodent Implant System-Easy Pack

K-Number: K203382 · 2021-03-15

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.
Decision Date2021-03-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System-Easy Pack is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2021-03-15 under 510(k) number K203382. 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-Easy Pack?

Neodent Implant System-Easy Pack is a medical device that received FDA 510(k) clearance on 2021-03-15. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K203382.

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

Neodent Implant System-Easy Pack received FDA 510(k) clearance on 2021-03-15, under 510(k) number K203382.

Who is the listed applicant for Neodent Implant System-Easy Pack?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S.A. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Neodent Implant System-Easy Pack is DZE.

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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