510(k) clearance
Calcium Hydroxide Temporary Filling Material (KP-Cal)
- 510(k) number
- K261514
- Applicant
- Guilin Kevin Peter Technology Co., Ltd.
- Decision date
- Aug 25, 2026
- Date received
- May 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KIF
- Device type
- Resin, Root Canal Filling
- Device class
- Class II
- Regulation
- 21 CFR 872.3820
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Guilin, CN