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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 K110719
Device Name ORIGIN ZIRCONIA
Applicant
B&D Dental Technologies
2371 S. Presidents Dr.,
Suite E
West Valley,  UT  84119
Applicant Contact JOON HWANG
Correspondent
B&D Dental Technologies
2371 S. Presidents Dr.,
Suite E
West Valley,  UT  84119
Correspondent Contact JOON HWANG
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/15/2011
Decision Date 08/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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