Calcium Hydroxide Temporary Filling Material (KP-Cal)— 510(k) K261514
Substantially EquivalentGuilin 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.
Summary
Guilin Kevin Peter Technology filed a Calcium Hydroxide Temporary Filling Material, listed as KP-Cal, under product code KIF, root canal filling resin.
Class II, 21 CFR 872.3820. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from Guilin, China. FDA found it substantially equivalent 110 calendar days after receipt (May 7 to August 25, 2026).
Clearance details
- Applicant
- Guilin Kevin Peter Technology Co., Ltd.
- Product code
- Product code KIF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3820
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guilin, CN
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