烏鴉夜間護牙器
K 號：K253641 · 2026-02-26
廣告
器材摘要
Owl Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Owl Dental Lab, Inc.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K253641. 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 Owl Night Guard?
Owl Night Guard is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Owl Dental Lab, Inc.. The 510(k) number is K253641.
When did Owl Night Guard receive FDA 510(k) clearance?
Owl Night Guard received FDA 510(k) clearance on 2026-02-26, under 510(k) number K253641.
Who is the listed applicant for Owl Night Guard?
The FDA 510(k) record lists Owl Dental Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Owl Night Guard?
The FDA product code for Owl Night Guard is OBR. This falls under the Orthopedic category.
相關臨床試驗
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。
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。
廣告