FDA 510(k)

Gingi-Aid Gel

K 號：K211419 · 2022-01-10

決定日期2022-01-10

產品代碼MVL

決定相當於

器材摘要

Gingi-Aid Gel is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2022-01-10 under 510(k) number K211419. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

常見問題

What is the Gingi-Aid Gel?

Gingi-Aid Gel is a medical device that received FDA 510(k) clearance on 2022-01-10. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K211419.

When did Gingi-Aid Gel receive FDA 510(k) clearance?

Gingi-Aid Gel received FDA 510(k) clearance on 2022-01-10, under 510(k) number K211419.

Who is the listed applicant for Gingi-Aid Gel?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gingi-Aid Gel?

The FDA product code for Gingi-Aid Gel is MVL.

其他以 Belport Company, Inc., Gingi-Pak 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。

K260430瓷刻膠 K251775RODIN 水泥 K250279RC-SwiftPrep K250222SDF Pro K240688RODIN 鐵砲3D膠質 K231060ProMin 齒齒敏感緩解膠

查看所有 11 項裝置 →

相關器械（代碼：MVL）

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。

K254239CyClean 線SS GLOBAL K253797一站式Mediclus Co., Ltd.K243910RetraxilKulzer, LLC K211420靜脈血栓形成治療凝胶Belport Company, Inc., Gingi-Pak K213149VOCO 收縮膠Voco GmbH K200764STATSTIXCentrix Incorporated

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。