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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 K945451
Device Name HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE
Applicant
Shofu Dental Corp.
4025 Bohannon Dr.
Menlo Park,  CA  94025
Applicant Contact BILL OESTREICH
Correspondent
Shofu Dental Corp.
4025 Bohannon Dr.
Menlo Park,  CA  94025
Correspondent Contact BILL OESTREICH
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/07/1994
Decision Date 02/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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