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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K231635
Device Name A-Line Advanced
Applicant
Biocetec Co., Ltd
RM 1001,1002, New T Castle, 108 Gasan Digital 2-Ro
Geumcheon-Gu
Seoul,  KR 08506
Applicant Contact Hee Sue Jin
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number872.5470
Classification Product Code
NJM  
Date Received06/05/2023
Decision Date 06/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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