FDA 510(k)

APAPRO Desensitizer Homecare (再礦化抗敏感牙膏)

K 號：K260830 · 2026-03-18

決定日期2026-03-18

產品代碼LBH

諮詢委員會DE

決定相當於

器材摘要

APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) is the device name listed in this FDA 510(k) record. The listed applicant is Sangi Co., Ltd.. It received FDA 510(k) clearance on 2026-03-18 under 510(k) number K260830. 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 APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)?

APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) is a medical device that received FDA 510(k) clearance on 2026-03-18. The listed applicant is Sangi Co., Ltd.. The 510(k) number is K260830.

When did APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) receive FDA 510(k) clearance?

APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) received FDA 510(k) clearance on 2026-03-18, under 510(k) number K260830.

Who is the listed applicant for APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)?

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

What is the FDA product code for APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)?

The FDA product code for APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) is LBH.

其他以 Sangi Co., Ltd. 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。

K220419Apapro去敏劑

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。

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官方來源

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