FDA 510(k)

TempFIT 暫時冠橋膠

K 號：K251271 · 2025-06-23

申請人Rizhao Huge Biomaterials Company, Ltd.

決定日期2025-06-23

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

TempFIT Temporary Crown and Bridge Resin is the device name listed in this FDA 510(k) record. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. It received FDA 510(k) clearance on 2025-06-23 under 510(k) number K251271. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TempFIT Temporary Crown and Bridge Resin?

TempFIT Temporary Crown and Bridge Resin is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K251271.

When did TempFIT Temporary Crown and Bridge Resin receive FDA 510(k) clearance?

TempFIT Temporary Crown and Bridge Resin received FDA 510(k) clearance on 2025-06-23, under 510(k) number K251271.

Who is the listed applicant for TempFIT Temporary Crown and Bridge Resin?

The FDA 510(k) record lists Rizhao Huge Biomaterials Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TempFIT Temporary Crown and Bridge Resin?

The FDA product code for TempFIT Temporary Crown and Bridge Resin is EBG.

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相關器械（代碼：EBG）

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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