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FDA 510(k)

Injectable Root Canal Sealer (KP-Root SP)

K-Number: K261415 · 2026-06-29

ApplicantGuilin Kevin Peter Technology Co., Ltd.
Decision Date2026-06-29
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Injectable Root Canal Sealer (KP-Root SP) is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K261415. 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 Sealer (KP-Root SP)?

Injectable Root Canal Sealer (KP-Root SP) is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Guilin Kevin Peter Technology Co., Ltd.. The 510(k) number is K261415.

When did Injectable Root Canal Sealer (KP-Root SP) receive FDA 510(k) clearance?

Injectable Root Canal Sealer (KP-Root SP) received FDA 510(k) clearance on 2026-06-29, under 510(k) number K261415.

Who is the listed applicant for Injectable Root Canal Sealer (KP-Root SP)?

The FDA 510(k) record lists Guilin Kevin Peter Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Injectable Root Canal Sealer (KP-Root SP)?

The FDA product code for Injectable Root Canal Sealer (KP-Root 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 SealersRECRUITINGNCT04757753Root 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_RECRUITINGNCT05714384Calcium Silicate Sealer-based Obturation in Root Canal RetreatmentCOMPLETEDNCT07526844Effect of Instrumentation Systems and Sealers on Postoperative PainNOT_YET_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.

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.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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