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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K191591
Device Name BB Base 3D printing resin for denture base
Applicant
Enlighten Materials Co., Ltd.
8f., #138, Sec.2, Jinshan S. Rd., Da-An Dist
Taipei,  TW 10642
Applicant Contact Jiun Ming Su
Correspondent
Voler Biotech Consulting CO., Ltd.
#3-1, Ln. 58, Hejiang St., Zhongshan Dist.,
Taipei City,  TW 10480
Correspondent Contact Chih-Hao Kao
Regulation Number872.3760
Classification Product Code
EBI  
Date Received06/14/2019
Decision Date 08/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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