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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Abutment Design Software For Dental Laboratory
510(k) Number K231529
Device Name CloudPoint FastDesign Chairside
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Applicant Contact Jiahe Li
Correspondent
Prismatik Dentalcraft, Inc.
2144 Michelson Dr.
Irvine,  CA  92612
Correspondent Contact Jiahe Li
Regulation Number872.3630
Classification Product Code
PNP  
Date Received05/26/2023
Decision Date 03/14/2024
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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