免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

牙齒去敏感劑

K 號:K222891 · 2023-05-25

決定日期2023-05-25
產品代碼LBH
諮詢委員會DE
決定相當於

器材摘要

Dental Desensitizer is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Beogene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K222891. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dental Desensitizer?

Dental Desensitizer is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Guangzhou Beogene Biotech Co., Ltd.. The 510(k) number is K222891.

When did Dental Desensitizer receive FDA 510(k) clearance?

Dental Desensitizer received FDA 510(k) clearance on 2023-05-25, under 510(k) number K222891.

Who is the listed applicant for Dental Desensitizer?

The FDA 510(k) record lists Guangzhou Beogene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Desensitizer?

The FDA product code for Dental Desensitizer is LBH.

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。

相關器械(代碼:LBH)

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑