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FDA 510(k)

NUVO IF Implant System

K-Number: K193234 · 2020-06-18

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.
Decision Date2020-06-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUVO IF Implant System is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2020-06-18 under approval number K193234. 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 NUVO IF Implant System?

NUVO IF Implant System is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K193234.

When was NUVO IF Implant System approved by the FDA?

NUVO IF Implant System received FDA 510(k) clearance on 2020-06-18, under approval number K193234.

What company makes NUVO IF Implant System?

NUVO IF Implant System is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A..

What is the FDA product code for NUVO IF Implant System?

The FDA product code for NUVO IF Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by Jjgc Industria E Comercio DE Materiais Dentarios S.A.

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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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