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 - Helix Short Surgical Kit Cases

K-Number: K223662 · 2023-04-20

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.
Decision Date2023-04-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - Helix Short Surgical Kit Cases 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 2023-04-20 under 510(k) number K223662. 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 Short Surgical Kit Cases?

Neodent Implant System - Helix Short Surgical Kit Cases is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K223662.

When did Neodent Implant System - Helix Short Surgical Kit Cases receive FDA 510(k) clearance?

Neodent Implant System - Helix Short Surgical Kit Cases received FDA 510(k) clearance on 2023-04-20, under 510(k) number K223662.

Who is the listed applicant for Neodent Implant System - Helix Short Surgical Kit Cases?

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 - Helix Short Surgical Kit Cases?

The FDA product code for Neodent Implant System - Helix Short Surgical Kit Cases is KCT.

Related Clinical Trials

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.

NCT00723944A Study of the Performance of Certain Prevail Implants Used in Short Fixed CasesCOMPLETEDNCT00728754A Study of Certain Prevail Implants Used for the Preservation of Crestal Bone in Short Fixed Bridge Cases.COMPLETED

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.

K222026Neodent Implant System - Zirconia Implant SystemK223638Neodent Implant System - Helix Short Implant SystemK220251Neodent Implant System - GM Narrow Implant SystemK210336Neodent Implant System - Zirconia Implant SystemK203542Neodent Implant System - Mini Abutment 60°K203382Neodent Implant System-Easy Pack

View all 28 devices →

Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

↑