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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 K180952
Device Name Ceramic Bracket
Applicant
MEM Dental Technology Co., Ltd
2F., No.22, Ln.31, Sec.1, Huandong Rd., Xinshi Dist.
Tainan City,  TW 74146
Applicant Contact Anita Chen
Correspondent
MEM Dental Technology Co., Ltd
2F., No.22, Ln.31, Sec.1, Huandong Rd., Xinshi Dist.
Tainan City,  TW 74146
Correspondent Contact Anita Chen
Regulation Number872.5470
Classification Product Code
NJM  
Date Received04/11/2018
Decision Date 06/07/2019
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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