Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Enpuno Co., Ltd.. It received FDA 510(k) clearance on 2025-06-11 under approval 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. It is manufactured by Enpuno Co., Ltd.. The 510(k) number is K250710.

When was Injectable Root Canal Bioceramic Sealer (nRoot SP) approved by the FDA?

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

What company makes Injectable Root Canal Bioceramic Sealer (nRoot SP)?

Injectable Root Canal Bioceramic Sealer (nRoot SP) is manufactured by Enpuno Co., Ltd..

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

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT05714384 Calcium Silicate Sealer-based Obturation in Root Canal Retreatment COMPLETED NCT04757753 Root Canal Obturation With a Ready-to-use Root Canal Sealer (PA1704) Versus BioRoot™ RCS: a Randomized Controlled Trial ACTIVE_NOT_RECRUITING NCT04945993 Tooth Retention After Root Canal Treatment With Endomethasone N ACTIVE_NOT_RECRUITING NCT04885686 Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP) COMPLETED NCT07526844 Effect of Instrumentation Systems and Sealers on Postoperative Pain NOT_YET_RECRUITING

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.

↑