FDA 510(k)

MIS LOCKiT 牙槽體系統，OT-等位線和球體連接件

K 號：K182228 · 2019-01-28

決定日期2019-01-28

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is the device name listed in this FDA 510(k) record. The listed applicant is Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K182228. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is Mis Implants Technologies , Ltd.. The 510(k) number is K182228.

When did MIS LOCKiT Abutments System, OT-Equators and Ball Attachments receive FDA 510(k) clearance?

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments received FDA 510(k) clearance on 2019-01-28, under 510(k) number K182228.

Who is the listed applicant for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

The FDA 510(k) record lists Mis Implants Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments?

The FDA product code for MIS LOCKiT Abutments System, OT-Equators and Ball Attachments is NHA.

其他以 Mis Implants Technologies , 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。

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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。

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官方來源

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