Ora-GUARD 齒齒磨損保護器
K 號：K150492 · 2016-02-19
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器材摘要
Ora-GUARD Dental Grind Guard is the device name listed in this FDA 510(k) record. The listed applicant is Bite Tech, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K150492. 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 Ora-GUARD Dental Grind Guard?
Ora-GUARD Dental Grind Guard is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Bite Tech, Inc.. The 510(k) number is K150492.
When did Ora-GUARD Dental Grind Guard receive FDA 510(k) clearance?
Ora-GUARD Dental Grind Guard received FDA 510(k) clearance on 2016-02-19, under 510(k) number K150492.
Who is the listed applicant for Ora-GUARD Dental Grind Guard?
The FDA 510(k) record lists Bite Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ora-GUARD Dental Grind Guard?
The FDA product code for Ora-GUARD Dental Grind 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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