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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 K222489
Device Name Harvest Printable Resin
Applicant
Harvest Dental Products, LLC
905 Columbia St.
Brea,  CA  92821
Applicant Contact Colleen Boswell
Correspondent
Harvest Dental Products, LLC
905 Columbia St.
Brea,  CA  92821
Correspondent Contact Colleen Boswell
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Codes
ELM   MQC  
Date Received08/17/2022
Decision Date 05/12/2023
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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