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

FDA 510(k)

Neodent Implant System - Custom Abutments

K-Number: K250614 · 2025-05-27

ApplicantJjgc Indústria E Comércia DE Materiais Dentários S.A.
Decision Date2025-05-27
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - Custom Abutments is a medical device manufactured by Jjgc Indústria E Comércia DE Materiais Dentários S.A.. It received FDA 510(k) clearance on 2025-05-27 under approval number K250614. 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 - Custom Abutments?

Neodent Implant System - Custom Abutments is a medical device that received FDA 510(k) clearance on 2025-05-27. It is manufactured by Jjgc Indústria E Comércia DE Materiais Dentários S.A.. The 510(k) number is K250614.

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

Neodent Implant System - Custom Abutments received FDA 510(k) clearance on 2025-05-27, under approval number K250614.

What company makes Neodent Implant System - Custom Abutments?

Neodent Implant System - Custom Abutments is manufactured by Jjgc Indústria E Comércia DE Materiais Dentários S.A..

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

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

Related Clinical Trials

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 NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING

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 Indústria E Comércia DE Materiais Dentários S.A.

K242686Neodent Implant System

Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, 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.

↑