FDA 510(k)

SleepRight ProRx + 自訂牙套，SleepRight ProRx 自訂牙套

K 號：K212706 · 2021-12-13

決定日期2021-12-13

產品代碼OBR

決定相當於

器材摘要

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom 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 2021-12-13 under 510(k) number K212706. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard?

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Splintek, Inc.. The 510(k) number is K212706.

When did SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard receive FDA 510(k) clearance?

SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212706.

Who is the listed applicant for SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom 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 ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard?

The FDA product code for SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard is OBR. This falls under the Orthopedic category.

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：OBR）

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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