FDA 510(k)

enCore 印記材質

K 號：K251926 · 2026-03-17

決定日期2026-03-17

產品代碼SHI

諮詢委員會DE

決定相當於

器材摘要

enCore Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Encore Guards. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K251926. The device is classified under product code SHI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the enCore Impression Material?

enCore Impression Material is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is Encore Guards. The 510(k) number is K251926.

When did enCore Impression Material receive FDA 510(k) clearance?

enCore Impression Material received FDA 510(k) clearance on 2026-03-17, under 510(k) number K251926.

Who is the listed applicant for enCore Impression Material?

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

What is the FDA product code for enCore Impression Material?

The FDA product code for enCore Impression Material is SHI.

其他以 Encore Guards 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。

K252004enCore 夜間護牙器

相關器械（代碼：SHI）

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。

K261888ClearClub 印象材質ClearClub K251724雷米印象材質Grindguard, Inc.

官方來源

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