FDA 510(k)

過度咬合蛀牙輔助設備

K 號：K212519 · 2022-05-10

決定日期2022-05-10

產品代碼MYN

諮詢委員會RA

決定相當於

器材摘要

Overjet Caries 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 2022-05-10 under 510(k) number K212519. 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 Caries Assist?

Overjet Caries Assist is a medical device that received FDA 510(k) clearance on 2022-05-10. The listed applicant is Overjet, Inc.. The 510(k) number is K212519.

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

Overjet Caries Assist received FDA 510(k) clearance on 2022-05-10, under 510(k) number K212519.

Who is the listed applicant for Overjet Caries 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 Caries Assist?

The FDA product code for Overjet Caries 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。

K261059過度突出多影像蛀牙及圖表輔助設備 K253930過度突出虹膜智能成像系統 K251514過顎CBCT輔助設備 K241681過顎影像強化輔助設備 K241684過顎圖表輔助設備 K233738過度咬合蛀牙輔助－兒童版

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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。

K252486胸腔視覺超音波儀 (1.1)Gleamer K261059過度突出多影像蛀牙及圖表輔助設備Overjet, Inc.K260851更好的診斷牙科輔助設備 (BDDA) 版本 1.0Better Diagnostics AI Corp.K252953維爾美尼牙醫用設備（V4D）牙髓牙周Velmeni, Inc.K251934qXR-DetectQure.Ai Technologies K252934診斷貓DGNCT, LLC

官方來源

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