510(k) clearance
Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
- 510(k) number
- K261695
- Applicant
- Guilin Kevin Peter Technology Co., Ltd.
- Decision date
- Aug 31, 2026
- Date received
- May 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EBF
- Device type
- Material, Tooth Shade, Resin
- Device class
- Class II
- Regulation
- 21 CFR 872.3690
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Guilin, CN