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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K261802
Device Name Glidewell™ Denture Base Resin
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 Number872.3760
Classification Product Code
EBI  
Date Received06/01/2026
Decision Date 08/27/2026
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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