FDA 510(k)

雷米印象材質

K 號：K251724 · 2026-02-25

決定日期2026-02-25

產品代碼SHI

諮詢委員會DE

決定相當於

器材摘要

Remi Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Grindguard, Inc.. It received FDA 510(k) clearance on 2026-02-25 under 510(k) number K251724. 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 Remi Impression Material?

Remi Impression Material is a medical device that received FDA 510(k) clearance on 2026-02-25. The listed applicant is Grindguard, Inc.. The 510(k) number is K251724.

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

Remi Impression Material received FDA 510(k) clearance on 2026-02-25, under 510(k) number K251724.

Who is the listed applicant for Remi Impression Material?

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

What is the FDA product code for Remi Impression Material?

The FDA product code for Remi Impression Material is SHI.

其他以 Grindguard, 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。

K243516Remi 訂製夜間護牙器

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 K251926enCore 印記材質Encore Guards

官方來源

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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。