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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 K160443
Device Name TempoCem Clear
Applicant
Dmg USA, Inc.
23 Frank Mossberg Dr.
Attleboro,  MA  02703
Applicant Contact Gordon Craig
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact Pam Papineau
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/17/2016
Decision Date 09/30/2016
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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