FDA 510(k)

過度顎尖顯影輔助設備

K 號：K231678 · 2023-09-21

決定日期2023-09-21

產品代碼MYN

諮詢委員會RA

決定相當於

器材摘要

Overjet Periapical Radiolucency Assist is the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2023-09-21 under 510(k) number K231678. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Overjet Periapical Radiolucency Assist?

Overjet Periapical Radiolucency Assist is a medical device that received FDA 510(k) clearance on 2023-09-21. The listed applicant is Overjet, Inc.. The 510(k) number is K231678.

When did Overjet Periapical Radiolucency Assist receive FDA 510(k) clearance?

Overjet Periapical Radiolucency Assist received FDA 510(k) clearance on 2023-09-21, under 510(k) number K231678.

Who is the listed applicant for Overjet Periapical Radiolucency Assist?

FDA 510(k) 記錄將 Overjet, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Overjet Periapical Radiolucency Assist?

The FDA product code for Overjet Periapical Radiolucency Assist is MYN.

其他以 Overjet, 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。

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相關器械（代碼：MYN）

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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