FDA 510(k)

正畸塑料牙套及配件

K 號：K180718 · 2018-10-30

決定日期2018-10-30

產品代碼DYW

諮詢委員會DE

決定相當於

器材摘要

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Tomy, Inc.. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K180718. 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 ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Tomy, Inc.. The 510(k) number is K180718.

When did ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES receive FDA 510(k) clearance?

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES received FDA 510(k) clearance on 2018-10-30, under 510(k) number K180718.

Who is the listed applicant for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

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

What is the FDA product code for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

The FDA product code for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is DYW.

其他以 Tomy, 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。

K160615正畸陶瓷托槽 1.1

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 K160720卡瑞爾動力潔淨二級Ortho Organizers, Inc.K150830CompleClear 塑膠正畸牙套及牙線設備Oracrew

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。