FDA 510(k)

Neodent儀器組盒

K 號：K190665 · 2019-12-23

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

決定日期2019-12-23

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Neodent Instrument 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 2019-12-23 under 510(k) number K190665. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neodent Instrument Kit Cases?

Neodent Instrument Kit Cases is a medical device that received FDA 510(k) clearance on 2019-12-23. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K190665.

When did Neodent Instrument Kit Cases receive FDA 510(k) clearance?

Neodent Instrument Kit Cases received FDA 510(k) clearance on 2019-12-23, under 510(k) number K190665.

Who is the listed applicant for Neodent Instrument 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 Instrument Kit Cases?

The FDA product code for Neodent Instrument Kit Cases is KCT.