CeraRoot TL 假牙系統 (TL)
K 號：K242072 · 2025-05-14
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器材摘要
CeraRoot TL Implant System (TL) is the device name listed in this FDA 510(k) record. The listed applicant is Ceraroot SL. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K242072. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CeraRoot TL Implant System (TL)?
CeraRoot TL Implant System (TL) is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Ceraroot SL. The 510(k) number is K242072.
When did CeraRoot TL Implant System (TL) receive FDA 510(k) clearance?
CeraRoot TL Implant System (TL) received FDA 510(k) clearance on 2025-05-14, under 510(k) number K242072.
Who is the listed applicant for CeraRoot TL Implant System (TL)?
The FDA 510(k) record lists Ceraroot SL as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CeraRoot TL Implant System (TL)?
The FDA product code for CeraRoot TL Implant System (TL) is DZE.
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相關器械（代碼：DZE）
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
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