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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 K261937
Device Name PacTemp Automix NE
Applicant
The Belport Company Inc., DBA Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Applicant Contact Nikki Huynh
Correspondent
The Belport Company Inc., DBA Gingi-Pak
4825 Calle Alto
Camarillo,  CA  93012
Correspondent Contact Nikki Huynh
Regulation Number872.3275
Classification Product Code
EMA  
Date Received06/10/2026
Decision Date 08/07/2026
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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