FDA 510(k)

Remi 訂製夜間護牙器

K 號：K243516 · 2025-02-10

決定日期2025-02-10

產品代碼MQC

決定相當於

器材摘要

Remi Custom Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Grindguard, Inc.. It received FDA 510(k) clearance on 2025-02-10 under 510(k) number K243516. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the Remi Custom Night Guard?

Remi Custom Night Guard is a medical device that received FDA 510(k) clearance on 2025-02-10. The listed applicant is Grindguard, Inc.. The 510(k) number is K243516.

When did Remi Custom Night Guard receive FDA 510(k) clearance?

Remi Custom Night Guard received FDA 510(k) clearance on 2025-02-10, under 510(k) number K243516.

Who is the listed applicant for Remi Custom Night Guard?

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 Custom Night Guard?

The FDA product code for Remi Custom Night Guard is MQC.

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。

K251724雷米印象材質

相關器械（代碼：MQC）

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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