FDA 510(k)

對稱潔淨

K 號：K172845 · 2018-01-31

決定日期2018-01-31

產品代碼NJM

諮詢委員會DE

決定相當於

器材摘要

Symetri Clear is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corporation. It received FDA 510(k) clearance on 2018-01-31 under 510(k) number K172845. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Symetri Clear?

Symetri Clear is a medical device that received FDA 510(k) clearance on 2018-01-31. The listed applicant is Ormco Corporation. The 510(k) number is K172845.

When did Symetri Clear receive FDA 510(k) clearance?

Symetri Clear received FDA 510(k) clearance on 2018-01-31, under 510(k) number K172845.

Who is the listed applicant for Symetri Clear?

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

What is the FDA product code for Symetri Clear?

The FDA product code for Symetri Clear is NJM.

其他以 Ormco Corporation 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。

K250487Spark™ 清晰正畸系統 K250015Ormco™ EtchFree 粘合系統，Ormco™ EtchFree 粘合底漆，Ormco™ EtchFree 黏合劑 K240501Spark™ 明亮正畸系統 K203737Spark 清晰正畸系統 K171844啟動 ICE 亦稱為啟動 ICE 清晰托架

相關器械（代碼：NJM）

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。

K232827LightForce 歸正系統Lightforce Orthodontics K232011CleoAmerican Orthodontics K231635A-Line 高級Biocetec Co., Ltd.K230225DynaFlex 清晰牙弓絲與按鈕Dyna Flex K222847陶瓷牙弓絲正畸器Orthometric - Industria E Comercio DE Produtos Medicos K222764LightForce 歸正系統Lightforce Orthodontics

官方來源

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