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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 K212939
Device Name Vintage Prime Press
Applicant
Shofu Dental Corporation
1225 Stone Dr.
San Marcos,  CA  92078
Applicant Contact Mauro Malzyner
Correspondent
Shofu Dental Corporation
1225 Stone Dr.
San Marcos,  CA  92078
Correspondent Contact Mauro Malzyner
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/15/2021
Decision Date 03/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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