510(k) K261695
K261695 is an FDA 510(k) premarket notification submitted by Guilin Kevin Peter Technology Co., Ltd. for the device "Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)". The FDA issued a decision of Substantially Equivalent on August 31, 2026. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Guilin Kevin Peter Technology Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2026
- Date Received
- May 22, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Tooth Shade, Resin
- Device Class
- Class II
- Regulation Number
- 872.3690
- Review Panel
- DE
- Submission Type