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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 K954177
Device Name ALPHA-BOND DENTIN BONDING SYSTEM
Applicant
Alpha-Bond, Inc.
22 W 246 Sunnyside Rd.
Medinah,  IL  60157
Applicant Contact GEORGE NICOLAE
Correspondent
Alpha-Bond, Inc.
22 W 246 Sunnyside Rd.
Medinah,  IL  60157
Correspondent Contact GEORGE NICOLAE
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/05/1995
Decision Date 09/27/1995
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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