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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K180578
Device Name Harvest Dental Polymer Blocks
Applicant
Harvest Dental Products, LLC
905 Columbia St.
Brea,  CA  92821
Applicant Contact Sasha Der Avanessian
Correspondent
Harvest Dental Products, LLC
905 Columbia St.
Brea,  CA  92821
Correspondent Contact Sasha Der Avanessian
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Codes
EBI   MQC  
Date Received03/05/2018
Decision Date 12/12/2018
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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