Calcium Hydroxide Temporary Filling Material (KP-Cal)— 510(k) K261514

Name: FDA 510(k) clearance K261514
Creator: U.S. Food and Drug Administration
Published: 2026-08-25

Substantially Equivalent

Guilin Kevin Peter Technology Co., Ltd.

FDA 510(k) clearance K261514 for Calcium Hydroxide Temporary Filling Material (KP-Cal), Substantially Equivalent on 2026-08-25. 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: 2026-05-07
Decision date: 2026-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilin, CN

Download summary PDF View on FDA.gov ↗

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