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510(k) K261415

Injectable Root Canal Sealer (KP-Root SP) by Guilin Kevin Peter Technology Co., Ltd. — Product Code KIF

K261415 is an FDA 510(k) premarket notification submitted by Guilin Kevin Peter Technology Co., Ltd. for the device "Injectable Root Canal Sealer (KP-Root SP)". The FDA issued a decision of Substantially Equivalent on June 29, 2026. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2026
Date Received
April 30, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type

Other clearances for product code KIF

  • K253167 — Any-Paste (January 12, 2026)
  • K252890 — ZenSeal Pro (January 7, 2026)
  • K251465 — Root canal repair materials (nRoot BP) (September 25, 2025)
  • K252285 — Well-Root PT (September 19, 2025)
  • K251884 — One-Fil Putty Injectable (August 22, 2025)
  • K251390 — MTA vpt (July 3, 2025)
  • K250710 — Injectable Root Canal Bioceramic Sealer (nRoot SP) (June 11, 2025)
  • K243353 — One-Fil Putty (March 14, 2025)
  • K243546 — AH Plus Endodontic Sealer (February 13, 2025)
  • K242934 — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (December 12, 2024)

FDA data resources