FDA 510(k)

超輕易

K 號：K261404 · 2026-04-30

決定日期2026-04-30

產品代碼LBH

諮詢委員會DE

決定相當於

器材摘要

UltraEZ is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2026-04-30 under 510(k) number K261404. 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 UltraEZ?

UltraEZ is a medical device that received FDA 510(k) clearance on 2026-04-30. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K261404.

When did UltraEZ receive FDA 510(k) clearance?

UltraEZ received FDA 510(k) clearance on 2026-04-30, under 510(k) number K261404.

Who is the listed applicant for UltraEZ?

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

What is the FDA product code for UltraEZ?

The FDA product code for UltraEZ is LBH.

其他以 Ultradent Products, Inc. 為申請人之記錄

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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。

K262243Profisil 免費Kettenbach GmbH & Co. KG K253052氟化膠漆（A型，C型）Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbH K260830APAPRO Desensitizer Homecare (再礦化抗敏感牙膏)Sangi Co., Ltd.K250714氟量膠漆Centrix, Inc.K243777Rennou™ 漆光劑（3% / 薄荷）；Rennou™ 漆光劑（3% / 草莓）；Rennou™ 漆光劑（3% / 樱桃）；Rennou™ 漆光劑（3% / 气球糖）Theodent, LLC

官方來源

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