Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Neodent Implant System - GM Narrow Implant System

K-Number: K220251 · 2022-09-06

Decision Date2022-09-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - GM Narrow Implant System 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 2022-09-06 under 510(k) number K220251. 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 Narrow Implant System?

Neodent Implant System - GM Narrow Implant System is a medical device that received FDA 510(k) clearance on 2022-09-06. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K220251.

When did Neodent Implant System - GM Narrow Implant System receive FDA 510(k) clearance?

Neodent Implant System - GM Narrow Implant System received FDA 510(k) clearance on 2022-09-06, under 510(k) number K220251.

Who is the listed applicant for Neodent Implant System - GM Narrow Implant System?

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 - GM Narrow Implant System?

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

Other records listing Jjgc Industria E Comercio DE Materiais Dentarios S.A. as applicant

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.

View all 28 devices →

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.

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.