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FDA 510(k)

SURGmatic S15 L Pro

K 號：K213139 · 2021-12-21

申請人Kavo Dental GmbH
決定日期2021-12-21
產品代碼EGS
諮詢委員會DE
決定相當於

器材摘要

SURGmatic S15 L Pro is the device name listed in this FDA 510(k) record. The listed applicant is Kavo Dental GmbH. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K213139. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SURGmatic S15 L Pro?

SURGmatic S15 L Pro is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Kavo Dental GmbH. The 510(k) number is K213139.

When did SURGmatic S15 L Pro receive FDA 510(k) clearance?

SURGmatic S15 L Pro received FDA 510(k) clearance on 2021-12-21, under 510(k) number K213139.

Who is the listed applicant for SURGmatic S15 L Pro?

The FDA 510(k) record lists Kavo Dental GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGmatic S15 L Pro?

The FDA product code for SURGmatic S15 L Pro is EGS.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：EGS）

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。

K251869一次性預防角（3399-60，3399-090，3399-105）Premium Plus (Dongguan) LimitedK240950一次性預防角Pacific Care LimitedK240183星 E900 手柄系列Dentalez, Inc., Stardental DivisionK230106一般切割直刀Nakanishi, Inc.K222518FX對抗Nakanishi, Inc.K220346蓮花牙科角Ajk Engineering, Inc.

官方來源

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