FDA 510(k)

SleepRight Select-舒適牙套

K 號：K212767 · 2021-12-22

決定日期2021-12-22

產品代碼MQC

決定相當於

器材摘要

SleepRight Select-Comfort Dental Guard is the device name listed in this FDA 510(k) record. The listed applicant is Splintek, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K212767. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常見問題

What is the SleepRight Select-Comfort Dental Guard?

SleepRight Select-Comfort Dental Guard is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Splintek, Inc.. The 510(k) number is K212767.

When did SleepRight Select-Comfort Dental Guard receive FDA 510(k) clearance?

SleepRight Select-Comfort Dental Guard received FDA 510(k) clearance on 2021-12-22, under 510(k) number K212767.

Who is the listed applicant for SleepRight Select-Comfort Dental Guard?

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

What is the FDA product code for SleepRight Select-Comfort Dental Guard?

The FDA product code for SleepRight Select-Comfort Dental Guard is MQC.

其他以 Splintek, 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。

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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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