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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 K261415
Device Name Injectable Root Canal Sealer (KP-Root SP)
Applicant
Guilin Kevin Peter Technology Co., Ltd.
North Side Of Linsu Rd., Lingui Town, Lingui Dist.
Guilin,  CN 541100
Applicant Contact Qian Zhang
Correspondent
ABMED Medical Technology PTY, Ltd.
48/6 Herbert St.
St Leonards,  AU 2065
Correspondent Contact Boyle Wang
Regulation Number872.3820
Classification Product Code
KIF  
Date Received04/30/2026
Decision Date 06/29/2026
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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