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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aligner, sequential
510(k) Number K181747
Device Name Orthodontic Appliance
Applicant
Shandong Huge Dental Material Corporation
No. 68 Shanhai Road, Donggang District
Rizhao City,  CN 276800
Applicant Contact Maggie Zheng
Correspondent
Shandong Huge Dental Material Corporation
No. 68 Shanhai Road, Donggang District
Rizhao City,  CN 276800
Correspondent Contact Maggie Zheng
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/02/2018
Decision Date 04/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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