FDA 510(k)

GR 整骨膠質系統

K 號：K211415 · 2021-10-21

決定日期2021-10-21

產品代碼MQC

決定相當於

器材摘要

GR Splint Resin System is the device name listed in this FDA 510(k) record. The listed applicant is Pro3Dure Medical GmbH. It received FDA 510(k) clearance on 2021-10-21 under 510(k) number K211415. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the GR Splint Resin System?

GR Splint Resin System is a medical device that received FDA 510(k) clearance on 2021-10-21. The listed applicant is Pro3Dure Medical GmbH. The 510(k) number is K211415.

When did GR Splint Resin System receive FDA 510(k) clearance?

GR Splint Resin System received FDA 510(k) clearance on 2021-10-21, under 510(k) number K211415.

Who is the listed applicant for GR Splint Resin System?

The FDA 510(k) record lists Pro3Dure Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GR Splint Resin System?

The FDA product code for GR Splint Resin System is MQC.

其他以 Pro3Dure Medical GmbH 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。

K212017Thermeo 系統 K210298GR-14 树脂系統 K201827GR-17 树脂系統

相關器械（代碼：MQC）

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。

K253798超印牙科硬式護牙套紫外線Guangzhou Heygears IMC., Inc.K250743Remvia 夜間護牙器Remvia K251252NOBILCAM 輻射盤Shandong Huge Dental Material Corporation K241729硬式支具 & 適應性熱療支具Whip Mix Corporation K243516Remi 訂製夜間護牙器Grindguard, Inc.K241369麗家夜護牙套Lijia, LLC

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。