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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 K231389
Device Name Harvest Dental HD Gum Strip
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 Code
EBF  
Date Received05/12/2023
Decision Date 08/16/2023
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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