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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K261514
Device Name Calcium Hydroxide Temporary Filling Material (KP-Cal)
Applicant
Guilin Kevin Peter Technology Co., Ltd.
North Side Of Linsu Rd., Lingui Town, Lingui Dist.
Guilin,  CN 541100
Applicant Contact Libin Zhang
Correspondent
Guilin Kevin Peter Technology Co., Ltd.
North Side Of Linsu Rd., Lingui Town, Lingui Dist.
Guilin,  CN 541100
Correspondent Contact Libin Zhang
Regulation Number872.3820
Classification Product Code
KIF  
Subsequent Product Code
EJK  
Date Received05/07/2026
Decision Date 08/25/2026
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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