FDA 510(k)

Spark 清晰正畸系統

K 號：K203737 · 2021-03-22

決定日期2021-03-22

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

Spark Clear Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corporation. It received FDA 510(k) clearance on 2021-03-22 under 510(k) number K203737. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spark Clear Aligner System?

Spark Clear Aligner System is a medical device that received FDA 510(k) clearance on 2021-03-22. The listed applicant is Ormco Corporation. The 510(k) number is K203737.

When did Spark Clear Aligner System receive FDA 510(k) clearance?

Spark Clear Aligner System received FDA 510(k) clearance on 2021-03-22, under 510(k) number K203737.

Who is the listed applicant for Spark Clear Aligner System?

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 Spark Clear Aligner System?

The FDA product code for Spark Clear Aligner System is NXC.

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 K172845對稱潔淨 K171844啟動 ICE 亦稱為啟動 ICE 清晰托架

相關器械（代碼：NXC）

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。

K260527臉部4D調整器Avinent Implant System S.L.U.K260788斯麥麗歐正畸器Smylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile系統Dror Orthodesign , Ltd.K251454清齊正齊器（SCF-3348）Beame Medical Technology (Shenzhen) Limited K250739Primeprint直接對齊器Dreve Dentamid GmbH

官方來源

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