FDA 510(k)

S-單一

K 號：K221317 · 2023-01-13

決定日期2023-01-13

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

S-Mono is the device name listed in this FDA 510(k) record. The listed applicant is Shinhung Mst Co., Ltd.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K221317. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the S-Mono?

S-Mono is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Shinhung Mst Co., Ltd.. The 510(k) number is K221317.

When did S-Mono receive FDA 510(k) clearance?

S-Mono received FDA 510(k) clearance on 2023-01-13, under 510(k) number K221317.

Who is the listed applicant for S-Mono?

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

What is the FDA product code for S-Mono?

The FDA product code for S-Mono is DZE.

其他以 Shinhung Mst 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。

K221752Stella K223395Luna 牙齒植體系統 K200189Luna 齒齒植體系統- 恢復式基座 K162867牙德恩牙植體系統 K160106LUNA 牙齒植體系統

相關器械（代碼：DZE）

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。

K261392三活牙植體系統Paragon Implant Mfg., LLC K260463ZEROS 齿科植體系統Zeros Co., Ltd.K251188UNIQA® 齿科植體系統Uniqa Dental, Ltd.K251232MegaGen 遺傳子顎骨牙植體系統Megagen Implant Co., Ltd.K250806牙齒植體系統A.B. Dental Devices , Ltd.K260006INOS系統Inosys, Inc.

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。