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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K213994
Device Name Flexible Block
Applicant
Shandong Huge Dental Material Corporation
# 68 Shanhai Rd., Donggang District
Rizhao City,  CN 276800
Applicant Contact Maggie Zheng
Correspondent
Shandong Huge Dental Material Corporation
# 68 Shanhai Rd., Donggang District
Rizhao City,  CN 276800
Correspondent Contact Maggie Zheng
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Code
MQC  
Date Received12/21/2021
Decision Date 03/04/2022
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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