FDA 510(k)

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

K-번호: K240304 · 2024-05-28

결정일2024-05-28

제품 코드KIF

자문 위원회DE

결정Substantially Equivalent

기기 요약

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) is the device name listed in this FDA 510(k) record. The listed applicant is Enpuno Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-28 under 510(k) number K240304. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)?

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) is a medical device that received FDA 510(k) clearance on 2024-05-28. The listed applicant is Enpuno Biotechnology Co., Ltd.. The 510(k) number is K240304.

When did Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) receive FDA 510(k) clearance?

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) received FDA 510(k) clearance on 2024-05-28, under 510(k) number K240304.

Who is the listed applicant for Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)?

The FDA 510(k) record lists Enpuno Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)?

The FDA product code for Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) is KIF.

Enpuno Biotechnology Co., Ltd.를 신청인으로 등재한 기타 기록

K251465Root canal repair materials (nRoot BP)

공식 출처

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