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FDA 510(k)

Neodent Implant System - Temporary Abutments

K-Number: K191191 · 2019-12-05

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.
Decision Date2019-12-05
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - Temporary Abutments is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2019-12-05 under approval number K191191. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neodent Implant System - Temporary Abutments?

Neodent Implant System - Temporary Abutments is a medical device that received FDA 510(k) clearance on 2019-12-05. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K191191.

When was Neodent Implant System - Temporary Abutments approved by the FDA?

Neodent Implant System - Temporary Abutments received FDA 510(k) clearance on 2019-12-05, under approval number K191191.

What company makes Neodent Implant System - Temporary Abutments?

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

What is the FDA product code for Neodent Implant System - Temporary Abutments?

The FDA product code for Neodent Implant System - Temporary Abutments is NHA.

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.

K160964Neodent Implant System - Titanium Base for CEREC K170080Neodent Implant System - CM Pro PEEK Abutment K163194Neodent Implant System - GM Line K180536Neodent Implant System – GM Line K173902Neodent Implant System – GM Line K171713Neodent Instrument Kits

View all 28 devices →

Related Devices (Code: NHA)

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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.

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