Neodent Implant System-Helix NGM Compact Surgical Kit Cases
K-Number: K214051 · 2022-04-13
Decision Date2022-04-13
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Neodent Implant System-Helix NGM Compact Surgical Kit Cases is a medical device manufactured by JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2022-04-13 under approval number K214051. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neodent Implant System-Helix NGM Compact Surgical Kit Cases?
Neodent Implant System-Helix NGM Compact Surgical Kit Cases is a medical device that received FDA 510(k) clearance on 2022-04-13. It is manufactured by JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K214051.
When was Neodent Implant System-Helix NGM Compact Surgical Kit Cases approved by the FDA?
Neodent Implant System-Helix NGM Compact Surgical Kit Cases received FDA 510(k) clearance on 2022-04-13, under approval number K214051.
What company makes Neodent Implant System-Helix NGM Compact Surgical Kit Cases?
Neodent Implant System-Helix NGM Compact Surgical Kit Cases is manufactured by JJGC Indústria e Comércio de Materiais Dentários S.A..
What is the FDA product code for Neodent Implant System-Helix NGM Compact Surgical Kit Cases?
The FDA product code for Neodent Implant System-Helix NGM Compact Surgical Kit Cases is KCT.
Related Clinical Trials
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
COMPLETED
NCT07301385
Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study
ACTIVE_NOT_RECRUITING
NCT07175129
Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI)
WITHDRAWN
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT07613892
Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
COMPLETED
Related PubMed Literature
PMID: 42201559
Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system.
Journal of robotic surgery (2026)
PMID: 41160299
Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication.
International journal of clinical oncology (2025)
PMID: 40775988
B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation.
Studies in health technology and informatics (2025)
PMID: 40346298
An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients.
NPJ digital medicine (2025)
Other Devices by JJGC Indústria e Comércio de Materiais Dentários S.A.
Related Devices (Code: KCT)
K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG
K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc.
K160912Sterilization TraySTERIS Corporation
K161347Signia sterilization trayCovidien
K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc.
K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.
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.