FDA 510(k)

Neodent Implant System - Helix Short Surgical Kit Cases

N.º K: K223662 · 2023-04-20

SolicitanteJjgc Industria E Comercio DE Materiais Dentarios S.A.

Fecha de decisión2023-04-20

Código de productoKCT

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Jjgc Industria E Comercio DE Materiais Dentarios S.A. como solicitante

K222026Neodent Implant System - Zirconia Implant System K223638Neodent Implant System - Helix Short Implant System K220251Neodent Implant System - GM Narrow Implant System K210336Neodent Implant System - Zirconia Implant System K203542Neodent Implant System - Mini Abutment 60°K203382Neodent Implant System-Easy Pack

Ver todos los 28 dispositivos →

Dispositivos relacionados (Código: KCT)

K253988LiteSet TraysNobel Biocare AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.