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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K182929
Device Name BIO-RAY A-1 Anchor Screw System
Applicant
Microware Precision Co., Ltd.
# 12, Keyuan 2nd Rd., Situn District,
Taichung City,  TW 40763
Applicant Contact Harrison Du
Correspondent
Microware Precision Co., Ltd.
# 12, Keyuan 2nd Rd., Situn District,
Taichung City,  TW 40763
Correspondent Contact Harrison Du
Regulation Number872.3640
Classification Product Code
OAT  
Date Received10/22/2018
Decision Date 11/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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