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FDA 510(k)

Injectable Root Canal Bioceramic Sealer (nRoot SP)

K-Number: K250710 · 2025-06-11

ApplicantEnpuno Co., Ltd.
Decision Date2025-06-11
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Injectable Root Canal Bioceramic Sealer (nRoot SP) is the device name listed in this FDA 510(k) record. The listed applicant is Enpuno Co., Ltd.. It received FDA 510(k) clearance on 2025-06-11 under 510(k) number K250710. 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 Injectable Root Canal Bioceramic Sealer (nRoot SP)?

Injectable Root Canal Bioceramic Sealer (nRoot SP) is a medical device that received FDA 510(k) clearance on 2025-06-11. The listed applicant is Enpuno Co., Ltd.. The 510(k) number is K250710.

When did Injectable Root Canal Bioceramic Sealer (nRoot SP) receive FDA 510(k) clearance?

Injectable Root Canal Bioceramic Sealer (nRoot SP) received FDA 510(k) clearance on 2025-06-11, under 510(k) number K250710.

Who is the listed applicant for Injectable Root Canal Bioceramic Sealer (nRoot SP)?

The FDA 510(k) record lists Enpuno 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 (nRoot SP)?

The FDA product code for Injectable Root Canal Bioceramic Sealer (nRoot SP) 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 SealersRECRUITINGNCT07526844Effect of Instrumentation Systems and Sealers on Postoperative PainNOT_YET_RECRUITINGNCT07608939Postoperative Pain After Root Canal Treatment Using Different Root Canal SealersNOT_YET_RECRUITINGNCT04757753Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled TrialACTIVE_NOT_RECRUITINGNCT04885686Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)COMPLETEDNCT04945993Tooth Retention After Root Canal Treatment With Endomethasone NACTIVE_NOT_RECRUITING

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 CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus 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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