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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mouthguard, prescription
510(k) Number K223798
Device Name Glidewell TuffSplint™ Appliance Resin
Applicant
Prismatik Dentalcraft, Inc.
2144 Michelson Drive
Irvine,  CA  92612
Applicant Contact Jiahe Li
Correspondent
Prismatik Dentalcraft, Inc.
2144 Michelson Drive
Irvine,  CA  92612
Correspondent Contact Jiahe Li
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received12/19/2022
Decision Date 02/17/2023
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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