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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 K982461
Device Name GLASIONOMER CEMENT CX PLUS
Applicant
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Applicant Contact THOMAS D YANKELITIS
Correspondent
Shofu Dental Corp.
4024 Bohannon Dr.
Menlo Park,  CA  94025
Correspondent Contact THOMAS D YANKELITIS
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/15/1998
Decision Date 08/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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