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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name agent, tooth bonding, resin
510(k) Number K222357
Device Name DenMat Glutaraldehyde Desensitizer
Applicant
DenMat Holding, LLC
1017 W. Central Avenue
Lompoc,  CA  93436
Applicant Contact Murisa Woodlin
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
LBH  
Date Received08/04/2022
Decision Date 08/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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