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FDA 510(k)

Neodent Implant System - GM Line

K-Number: K163194 · 2017-07-14

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.
Decision Date2017-07-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - GM Line is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2017-07-14 under approval number K163194. 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 - GM Line?

Neodent Implant System - GM Line is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K163194.

When was Neodent Implant System - GM Line approved by the FDA?

Neodent Implant System - GM Line received FDA 510(k) clearance on 2017-07-14, under approval number K163194.

What company makes Neodent Implant System - GM Line?

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

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

The FDA product code for Neodent Implant System - GM Line is DZE.

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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.

K160964Neodent Implant System - Titanium Base for CEREC K170080Neodent Implant System - CM Pro PEEK Abutment K180536Neodent Implant System – GM Line K173902Neodent Implant System – GM Line K171713Neodent Instrument Kits K190665Neodent Instrument Kit Cases

View all 28 devices →

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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