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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K193090
Device Name HCG Zirconia Ceramic Block
Applicant
Hocheng Corporation
1f.,#398, Xingshan Rd., Neihu Dist.
Taipei City,  TW 11469
Applicant Contact Chieh-Ju Huang
Correspondent
Hocheng Corporation
1f.,#398, Xingshan Rd., Neihu Dist.
Taipei City,  TW 11469
Correspondent Contact Chieh-Ju Huang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received11/06/2019
Decision Date 10/29/2020
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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