FBCC 夜間護牙器
K 號：K221369 · 2022-11-18
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器材摘要
FBCC Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Fbcc, Inc.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K221369. 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 FBCC Night Guard?
FBCC Night Guard is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Fbcc, Inc.. The 510(k) number is K221369.
When did FBCC Night Guard receive FDA 510(k) clearance?
FBCC Night Guard received FDA 510(k) clearance on 2022-11-18, under 510(k) number K221369.
Who is the listed applicant for FBCC Night Guard?
The FDA 510(k) record lists Fbcc, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FBCC Night Guard?
The FDA product code for FBCC Night Guard is OBR. This falls under the Orthopedic category.
相關臨床試驗
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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。
官方來源
在 FDA 資料庫中查看 →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。
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