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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 a medical device manufactured by Enpuno Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-25 under approval 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. It is manufactured by Enpuno Biotechnology Co., Ltd.. The 510(k) number is K251465.

When was Root canal repair materials (nRoot BP) approved by the FDA?

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

What company makes Root canal repair materials (nRoot BP)?

Root canal repair materials (nRoot BP) is manufactured by Enpuno Biotechnology Co., Ltd..

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

NCT04945993 Tooth Retention After Root Canal Treatment With Endomethasone N ACTIVE_NOT_RECRUITING NCT07388901 In Vivo Study on the Material Properties of iRoot SP and nRoot SP Root Canal Sealers RECRUITING

Other Devices by Enpuno Biotechnology Co., Ltd.

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)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental Specialties K170950Well-Root STVericom Co., Ltd.

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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