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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 K250710
Device Name Injectable Root Canal Bioceramic Sealer (nRoot SP)
Applicant
Enpuno Co., Ltd.
# 201, Haiping Park Production Plant3
#229, Guyuan Rd. Changsha High-Tech Development Zone
Changsha,  CN 410205
Applicant Contact Chengfa Huang
Correspondent
Enpuno Co., Ltd.
# 201, Haiping Park Production Plant3
#229, Guyuan Rd. Changsha High-Tech Development Zone
Changsha,  CN 410205
Correspondent Contact Chengfa Huang
Regulation Number872.3820
Classification Product Code
KIF  
Date Received03/10/2025
Decision Date 06/11/2025
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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