FDA 510(k)

Neodent植牙系統

K 號：K190958 · 2019-11-09

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

決定日期2019-11-09

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Neodent Implant System 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 2019-11-09 under 510(k) number K190958. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neodent Implant System?

Neodent Implant System is a medical device that received FDA 510(k) clearance on 2019-11-09. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K190958.

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

Neodent Implant System received FDA 510(k) clearance on 2019-11-09, under 510(k) number K190958.

Who is the listed applicant for Neodent Implant System?

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?

The FDA product code for Neodent Implant System is DZE.