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FDA 510(k)

Root canal repair materials (nRoot BP)

K-Number: K251465 · 2025-09-25

ApplicantEnpuno Biotechnology Co., Ltd.
Decision Date2025-09-25
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Root canal repair materials (nRoot BP) 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 2025-09-25 under 510(k) number K251465. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Root canal repair materials (nRoot BP)?

Root canal repair materials (nRoot BP) is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Enpuno Biotechnology Co., Ltd.. The 510(k) number is K251465.

When did Root canal repair materials (nRoot BP) receive FDA 510(k) clearance?

Root canal repair materials (nRoot BP) received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251465.

Who is the listed applicant for Root canal repair materials (nRoot BP)?

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 Root canal repair materials (nRoot BP)?

The FDA product code for Root canal repair materials (nRoot BP) is KIF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07388901In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal SealersRECRUITINGNCT04945993Tooth Retention After Root Canal Treatment With Endomethasone NACTIVE_NOT_RECRUITINGNCT07246512A Comparative Analysis of Biomaterials for Retrograde Filling in Apical Surgery.COMPLETEDNCT07642284Clinical Performance of AH Plus Jet® Root Canal Sealers in Single-cone ProtocolsNOT_YET_RECRUITINGNCT07642596EFFECT OF NITI SYSTEMS AND XP-ENDO FINISHER ON POSTOPERATIVE PAINRECRUITING

Other records listing Enpuno Biotechnology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240304Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus Co., Ltd.K251390MTA vptVoco GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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