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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K241056
Device Name Light Cure Adhesive
Applicant
Sincera Technology (Changchun) Co., Ltd.
# 177 Changda Rd., Hi-Tech District, Changchun City
Jilin Province
Changchun,  CN
Applicant Contact Tony Su
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg.,
1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/18/2024
Decision Date 07/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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