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FDA 510(k)

Zygomatic Implants

K-Number: K190718 · 2019-07-11

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.
Decision Date2019-07-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zygomatic Implants is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2019-07-11 under approval number K190718. 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 Zygomatic Implants?

Zygomatic Implants is a medical device that received FDA 510(k) clearance on 2019-07-11. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K190718.

When was Zygomatic Implants approved by the FDA?

Zygomatic Implants received FDA 510(k) clearance on 2019-07-11, under approval number K190718.

What company makes Zygomatic Implants?

Zygomatic Implants is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A..

What is the FDA product code for Zygomatic Implants?

The FDA product code for Zygomatic Implants is DZE.

Related Clinical Trials

NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING

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Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., 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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