FDA 510(k)

Neodent植牙系統 - NeoConvert Fit

K 號：K261147 · 2026-07-01

申請人JJGC Indústria e Comércio de Materiais Dentários S.A.

決定日期2026-07-01

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Neodent Implant System - NeoConvert Fit 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 2026-07-01 under 510(k) number K261147. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neodent Implant System - NeoConvert Fit?

Neodent Implant System - NeoConvert Fit is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K261147.

When did Neodent Implant System - NeoConvert Fit receive FDA 510(k) clearance?

Neodent Implant System - NeoConvert Fit received FDA 510(k) clearance on 2026-07-01, under 510(k) number K261147.

Who is the listed applicant for Neodent Implant System - NeoConvert Fit?

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 - NeoConvert Fit?

The FDA product code for Neodent Implant System - NeoConvert Fit is NHA.