FDA 510(k)

石咬與石咬掃描

K 號：K190571 · 2019-11-07

決定日期2019-11-07

產品代碼ELW

諮詢委員會DE

決定相當於

器材摘要

StoneBite and StoneBite scan is the device name listed in this FDA 510(k) record. The listed applicant is Dreve Dentamid GmbH. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K190571. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StoneBite and StoneBite scan?

StoneBite and StoneBite scan is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Dreve Dentamid GmbH. The 510(k) number is K190571.

When did StoneBite and StoneBite scan receive FDA 510(k) clearance?

StoneBite and StoneBite scan received FDA 510(k) clearance on 2019-11-07, under 510(k) number K190571.

Who is the listed applicant for StoneBite and StoneBite scan?

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

What is the FDA product code for StoneBite and StoneBite scan?

The FDA product code for StoneBite and StoneBite scan is ELW.

其他以 Dreve Dentamid GmbH 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：ELW）

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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