FDA 510(k)

Neodent植牙系統 - 暫時性基座

K 號：K191191 · 2019-12-05

申請人Jjgc Industria E Comercio DE Materiais Dentarios S.A.

決定日期2019-12-05

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Neodent Implant System - Temporary Abutments 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 2019-12-05 under 510(k) number K191191. 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 - Temporary Abutments?

Neodent Implant System - Temporary Abutments is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K191191.

When did Neodent Implant System - Temporary Abutments receive FDA 510(k) clearance?

Neodent Implant System - Temporary Abutments received FDA 510(k) clearance on 2019-12-05, under 510(k) number K191191.

Who is the listed applicant for Neodent Implant System - Temporary Abutments?

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 - Temporary Abutments?

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