FDA 510(k)

Spark™ 明亮正畸系統

K 號：K240501 · 2024-10-11

決定日期2024-10-11

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 2024-10-11 under 510(k) number K240501. 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 2024-10-11. The listed applicant is Ormco Corporation. The 510(k) number is K240501.

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

Spark™ Clear Aligner System received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240501.

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 K203737Spark 清晰正畸系統 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

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。