FDA 510(k)

特拉烏斯牙科手術器械

K 號：K182892 · 2019-11-26

決定日期2019-11-26

產品代碼EGS

諮詢委員會DE

決定相當於

器材摘要

TRAUS Dental Handpieces is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K182892. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TRAUS Dental Handpieces?

TRAUS Dental Handpieces is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K182892.

When did TRAUS Dental Handpieces receive FDA 510(k) clearance?

TRAUS Dental Handpieces received FDA 510(k) clearance on 2019-11-26, under 510(k) number K182892.

Who is the listed applicant for TRAUS Dental Handpieces?

The FDA 510(k) record lists Saeshin Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAUS Dental Handpieces?

The FDA product code for TRAUS Dental Handpieces is EGS.

其他以 Saeshin Precision Co., Ltd. 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。

K251407電動手持式工具及控制單元（SDI10）K233153Traus SSG10 外科系統 K232938Traus SSG30 外科系統 K221741TRAUS空氣牙科手持工具 K212043特拉烏內科醫療設備 FDA、510(k)、PMA、NCT、PMID、識別碼及網址政策：醫療規範-v1 K201292TRAUS SIP20

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相關器械（代碼：EGS）

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。

K251869一次性預防角（3399-60，3399-090，3399-105）Premium Plus (Dongguan) Limited K240950一次性預防角Pacific Care Limited K240183星 E900 手柄系列Dentalez, Inc., Stardental Division K230106一般切割直刀Nakanishi, Inc.K222518FX對抗Nakanishi, Inc.K220346蓮花牙科角Ajk Engineering, Inc.

官方來源

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