FDA 510(k)

Neodent Implant System-Helix NGM Compact Surgical Kit Cases

N.º K: K214051 · 2022-04-13

SolicitanteJJGC Indústria e Comércio de Materiais Dentários S.A.

Fecha de decisión2022-04-13

Código de productoKCT

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Neodent Implant System-Helix NGM Compact Surgical Kit Cases is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2022-04-13 under 510(k) number K214051. 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 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. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K214051.

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

Neodent Implant System-Helix NGM Compact Surgical Kit Cases received FDA 510(k) clearance on 2022-04-13, under 510(k) number K214051.

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

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários 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 NGM Compact Surgical Kit Cases?

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

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Otros registros que enlistan a JJGC Indústria e Comércio de Materiais Dentários S.A. como solicitante

K261147Neodent Implant System - NeoConvert Fit K253922Neodent Scannable Healing Abutment K252727Neodent InLab Validated Workflow K252090Pterygoid Indication for GM Helix Implants K250271Neodent Implant System - Zirconia Implant System K241492Cajas de Kit de Cirugía Guiada

Ver todos los 12 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

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