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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K191122
Device Name 3M RelyX Pediatric Resin Modified Glass Ionomer Cement
Applicant
3M Espe Dental Products
2510 Conway Ave.
Saint Paul,  MN  55144
Applicant Contact Lin Ma
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number872.3275
Classification Product Code
EMA  
Date Received04/29/2019
Decision Date 05/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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