FDA 510(k)

明亮腔道覆蓋物

K 號：K253248 · 2026-01-13

決定日期2026-01-13

產品代碼EJK

諮詢委員會DE

決定相當於

器材摘要

Bright Cavity Liner is the device name listed in this FDA 510(k) record. The listed applicant is Dmp Dental Industry S.A.. It received FDA 510(k) clearance on 2026-01-13 under 510(k) number K253248. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bright Cavity Liner?

Bright Cavity Liner is a medical device that received FDA 510(k) clearance on 2026-01-13. The listed applicant is Dmp Dental Industry S.A.. The 510(k) number is K253248.

When did Bright Cavity Liner receive FDA 510(k) clearance?

Bright Cavity Liner received FDA 510(k) clearance on 2026-01-13, under 510(k) number K253248.

Who is the listed applicant for Bright Cavity Liner?

The FDA 510(k) record lists Dmp Dental Industry S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bright Cavity Liner?

The FDA product code for Bright Cavity Liner is EJK.

其他以 Dmp Dental Industry S.A. 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。

K252469MAGNABOND SE；MAGNABOND UNIVERSAL；MAGNABOND UNIVERSAL DCA K192830明顯臨時C&B

相關器械（代碼：EJK）

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。

K261728One-Fil LCMediclus Co., Ltd.K2302703M™ VitCal Liner/Base3M Espe Dental Products K212475Prevest Denpro 腺體洞線材（Apacal ART、Cal LC、Calcigel、CalUltra）Prevest Denpro Limited K201799清潔凈化器Maruchi K202413LC 树脂計算器 PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH K191103帕克爾敏感去除膠Parkell, Inc.

官方來源

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