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FDA 510(k)

Neodent Implant System - GM Helix Implants 7.0

K-Number: K201225 · 2020-09-04

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.
Decision Date2020-09-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - GM Helix Implants 7.0 is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2020-09-04 under approval number K201225. 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 Helix Implants 7.0?

Neodent Implant System - GM Helix Implants 7.0 is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K201225.

When was Neodent Implant System - GM Helix Implants 7.0 approved by the FDA?

Neodent Implant System - GM Helix Implants 7.0 received FDA 510(k) clearance on 2020-09-04, under approval number K201225.

What company makes Neodent Implant System - GM Helix Implants 7.0?

Neodent Implant System - GM Helix Implants 7.0 is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A..

What is the FDA product code for Neodent Implant System - GM Helix Implants 7.0?

The FDA product code for Neodent Implant System - GM Helix Implants 7.0 is DZE.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41987831 From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development. JOR spine (2026) PMID: 41620260 [Breast implants and cancer: Anaplastic large cell lymphoma in breast implants]. Annales de chirurgie plastique et esthetique (2026)

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: 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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