FDA 510(k)

Aidite PMMA

K 號：K190217 · 2020-12-17

申請人Aidite (Qinhuangdao) Technology Co., Ltd.

決定日期2020-12-17

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

Aidite PMMA is the device name listed in this FDA 510(k) record. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-17 under 510(k) number K190217. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aidite PMMA?

Aidite PMMA is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K190217.

When did Aidite PMMA receive FDA 510(k) clearance?

Aidite PMMA received FDA 510(k) clearance on 2020-12-17, under 510(k) number K190217.

Who is the listed applicant for Aidite PMMA?

The FDA 510(k) record lists Aidite (Qinhuangdao) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aidite PMMA?

The FDA product code for Aidite PMMA is EBG.

其他以 Aidite (Qinhuangdao) Technology Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253036光固化顏色材料（ALCM）K251415Additively Manufactured Aligner Resin K250534比米克顏色不透明 K250497附加製造（光固化）牙冠橋樑膠 K250811牙醫氧化鋁陶瓷 K250025瓷粉（釉/調節劑，著色/釉，著色/釉-A，塑形液）

查看所有 16 項裝置 →

相關器械（代碼：EBG）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT 基座”及“FLNT 溫度”Liaoning Upcera Co., Ltd.K251271TempFIT 暫時冠橋膠Rizhao Huge Biomaterials Company, Ltd.K243370牙齒牙齒Asiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E Exportação K243951TEMP MASTER，基於PMMA的牙科树脂Taiwan Dental Materials Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。