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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 K220816
Device Name BruxZir NOW
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Drive
Irvine,  CA  96212
Applicant Contact So Hyun Park
Correspondent
Prismatik Dentalcraft, Inc.
2144 Michelson Drive
Irvine,  CA  96212
Correspondent Contact So Hyun Park
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/21/2022
Decision Date 08/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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