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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 K192767
Device Name Clear Aligner
Applicant
Royal Dental Lab
F/1, 2, 3, 5, 6, Building 2, No. 4 West Area, Shangxue
Industry Park, Bantian, Lon
Shenzhen,  CN 518129
Applicant Contact Mo Yuyun
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
B-3F-3005, Bldg I, Southward Ruifeng Business Center, No.22
Guimiao Rd.
Shenzhen,  CN 518000
Correspondent Contact Becky Chen
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/30/2019
Decision Date 01/08/2020
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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