FDA 510(k)

過度咬合蛀牙輔助－兒童版

K 號：K233738 · 2024-03-04

決定日期2024-03-04

產品代碼MYN

諮詢委員會RA

決定相當於

器材摘要

Overjet Caries Assist-Pediatric is the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2024-03-04 under 510(k) number K233738. 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-Pediatric?

Overjet Caries Assist-Pediatric is a medical device that received FDA 510(k) clearance on 2024-03-04. The listed applicant is Overjet, Inc.. The 510(k) number is K233738.

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

Overjet Caries Assist-Pediatric received FDA 510(k) clearance on 2024-03-04, under 510(k) number K233738.

Who is the listed applicant for Overjet Caries Assist-Pediatric?

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-Pediatric?

The FDA product code for Overjet Caries Assist-Pediatric 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 K233590過顎圖表輔助設備

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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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