FDA 510(k)

TopCEM Dual Cure Resin Cement

K-번호: K233082 · 2023-12-22

신청자Rizhao Huge Biomaterials Company, Ltd.

결정일2023-12-22

제품 코드EBF

자문 위원회의료 장비 규제 텍스트 번역 DE [회사명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료 장비로, 510(k) 신청을 통해 승인을 받았습니다. 이 제품은 PMA(Premarket Approval)를 받지 않았으며, NCT(National Clinical Trial) 등록 번호는 [NCT 번호]입니다. PMID(Publication Medical Identifier)은 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL]

결정Substantially Equivalent

기기 요약

TopCEM Dual Cure Resin Cement 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 2023-12-22 under 510(k) number K233082. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TopCEM Dual Cure Resin Cement?

TopCEM Dual Cure Resin Cement is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Rizhao Huge Biomaterials Company, Ltd.. The 510(k) number is K233082.

When did TopCEM Dual Cure Resin Cement receive FDA 510(k) clearance?

TopCEM Dual Cure Resin Cement received FDA 510(k) clearance on 2023-12-22, under 510(k) number K233082.

Who is the listed applicant for TopCEM Dual Cure Resin Cement?

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 TopCEM Dual Cure Resin Cement?

The FDA product code for TopCEM Dual Cure Resin Cement is EBF.

Rizhao Huge Biomaterials Company, Ltd.를 신청인으로 등재한 기타 기록

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