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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K251578
Device Name BEAUTIFIL II
Applicant
Shofu Dental Corporation
1225 Stone Dr.
San Marcos,  CA  92078
Applicant Contact Malzyner Mauro
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/22/2025
Decision Date 05/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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