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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 K971927
Device Name HI DENSE TC
Applicant
Shofu Dental Corp.
4025 Bohannon Dr.
Menlo Park,  CA  94025 -1096
Applicant Contact HIDEAKI KUMAZAWA
Correspondent
Shofu Dental Corp.
4025 Bohannon Dr.
Menlo Park,  CA  94025 -1096
Correspondent Contact HIDEAKI KUMAZAWA
Regulation Number872.3275
Classification Product Code
EMA  
Date Received05/27/1997
Decision Date 06/30/1997
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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