Injectable Root Canal Sealer (KP-Root SP)— 510(k) K261415
Substantially EquivalentGuilin 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.
Summary
Guilin Kevin Peter Technology's Injectable Root Canal Sealer (KP-Root SP) is filed under KIF, root canal filling resins. The record doesn't give the sealer's composition.
Class II, 21 CFR 872.3820. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
The applicant filed from Guilin, China. The decision came 60 calendar days after FDA received it (April 30 to June 29, 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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