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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K261695
Device Name Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
Applicant
Guilin Kevin Peter Technology Co., Ltd.
North Side Of Linsu Rd., Lingui Town, Lingui Dist.
Guilin,  CN 541100
Applicant Contact Qian Zhang
Correspondent
Guilin Kevin Peter Technology Co., Ltd.
North Side Of Linsu Rd., Lingui Town, Lingui Dist.
Guilin,  CN 541100
Correspondent Contact Qian Zhang
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
EBC  
Date Received05/22/2026
Decision Date 08/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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