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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 K251593
Device Name DenMat Multilayered Zirconia Disc
Applicant
Denmat Holding, LLC
1017 W. Central Ave.
Lompoc,  CA  93436
Applicant Contact Kimberly Maynes
Correspondent
Denmat Holding, LLC
1017 W. Central Ave.
Lompoc,  CA  93436
Correspondent Contact Kimberly Maynes
Regulation Number872.6660
Classification Product Code
EIH  
Date Received05/27/2025
Decision Date 08/25/2025
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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