Injectable Root Canal Sealer (KP-Root SP)— 510(k) K261415

Name: FDA 510(k) clearance K261415
Creator: U.S. Food and Drug Administration
Published: 2026-06-29

Substantially Equivalent

Guilin Kevin Peter Technology Co., Ltd.

FDA 510(k) clearance K261415 for Injectable Root Canal Sealer (KP-Root SP), Substantially Equivalent on 2026-06-29. Applicant: Guilin Kevin Peter Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guilin Kevin Peter Technology Co., Ltd.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2026-04-30
Decision date: 2026-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilin, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

view all

K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K253167 — Any-Paste2026-01-12
K252890 — ZenSeal Pro2026-01-07
K251465 — Root canal repair materials (nRoot BP)2025-09-25
K252285 — Well-Root PT2025-09-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.