FDA 510(k)

卡瑞爾動力潔淨二級

K 號：K160720 · 2016-11-28

決定日期2016-11-28

產品代碼DYW

諮詢委員會DE

決定相當於

器材摘要

Carriere Motion Clear Class II is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Organizers, Inc.. It received FDA 510(k) clearance on 2016-11-28 under 510(k) number K160720. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Carriere Motion Clear Class II?

Carriere Motion Clear Class II is a medical device that received FDA 510(k) clearance on 2016-11-28. The listed applicant is Ortho Organizers, Inc.. The 510(k) number is K160720.

When did Carriere Motion Clear Class II receive FDA 510(k) clearance?

Carriere Motion Clear Class II received FDA 510(k) clearance on 2016-11-28, under 510(k) number K160720.

Who is the listed applicant for Carriere Motion Clear Class II?

The FDA 510(k) record lists Ortho Organizers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Carriere Motion Clear Class II?

The FDA product code for Carriere Motion Clear Class II is DYW.

其他以 Ortho Organizers, Inc. 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。

K252760Carriere® 運動專業® 清晰咬合矯正器 K173440卡瑞爾 SLX 3D 透明

相關器械（代碼：DYW）

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。

K252760Carriere® 運動專業® 清晰咬合矯正器Ortho Organizers, Inc.K251196複合正畸托槽及按鈕Ec Certification Service GmbH K201940需求式支具Braces on Demand, Inc.K182338藍天生物電子正畸牙弓絲系統Blue Sky Bio K180718正畸塑料牙套及配件Tomy, Inc.K150830CompleClear 塑膠正畸牙套及牙線設備Oracrew

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