FDA 510(k)

DenMat 輔酶醛去敏劑

K 號：K222357 · 2022-08-09

決定日期2022-08-09

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

DenMat Glutaraldehyde Desensitizer is the device name listed in this FDA 510(k) record. The listed applicant is Denmat Holding, LLC. It received FDA 510(k) clearance on 2022-08-09 under 510(k) number K222357. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DenMat Glutaraldehyde Desensitizer?

DenMat Glutaraldehyde Desensitizer is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Denmat Holding, LLC. The 510(k) number is K222357.

When did DenMat Glutaraldehyde Desensitizer receive FDA 510(k) clearance?

DenMat Glutaraldehyde Desensitizer received FDA 510(k) clearance on 2022-08-09, under 510(k) number K222357.

Who is the listed applicant for DenMat Glutaraldehyde Desensitizer?

The FDA 510(k) record lists Denmat Holding, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DenMat Glutaraldehyde Desensitizer?

The FDA product code for DenMat Glutaraldehyde Desensitizer is KLE.

其他以 Denmat Holding, LLC 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。

K251593DenMat 多層氧化鋁礦碟

相關器械（代碼：KLE）

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。

K262252MPa 最大膠粘劑Den-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430瓷刻膠Belport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ 過敏性膠粘劑Premier Dental Products Company K251587VITA VMLC 基質Vita Zahnfabrik H. Rauter GmbH & Co. Kg.

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。