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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 K240882
Device Name BruxZir® Esthetic
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Applicant Contact So Hyun Park
Correspondent
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Correspondent Contact So Hyun Park
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/01/2024
Decision Date 05/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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