FDA 510(k)

帕克爾牙齒溝縫密封劑

K 號：K243254 · 2025-08-08

決定日期2025-08-08

產品代碼EBC

諮詢委員會DE

決定相當於

器材摘要

Parkell Pit and Fissure Sealant is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K243254. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Parkell Pit and Fissure Sealant?

Parkell Pit and Fissure Sealant is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Parkell, Inc.. The 510(k) number is K243254.

When did Parkell Pit and Fissure Sealant receive FDA 510(k) clearance?

Parkell Pit and Fissure Sealant received FDA 510(k) clearance on 2025-08-08, under 510(k) number K243254.

Who is the listed applicant for Parkell Pit and Fissure Sealant?

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

What is the FDA product code for Parkell Pit and Fissure Sealant?

The FDA product code for Parkell Pit and Fissure Sealant is EBC.

其他以 Parkell, Inc. 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。

K210259帕克爾自粘合膠泥 K191103帕克爾敏感去除膠 K190930SmarTemp X1 K182296超濾-LV K172176帕克爾普通用膠粘劑

相關器械（代碼：EBC）

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。

K260819Any-Com 密封Mediclus Co., Ltd.K232498超密封XT plus - 豐比奧生物保護，超密封XT hydro - 豐比奧生物保護Ultradent Product, Inc.K230455珐琅塗層膠Rizhao Huge Biomaterials Company, Ltd.K190998BA 牙齒溝縫密封劑Apex Dental Materials, Inc.K190339赫利奧斯密封F+Ivoclar Vivadent, AG K172169Pulpdent (Activa) 齿溝裂縫填充劑含MCPPulpdent Corporation

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。