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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 K101869
Device Name PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
Applicant
Silmet , Ltd.
12 Hasadna
Or Yehuda,  IL 60200
Applicant Contact SHARON CHAPLIK
Correspondent
Silmet , Ltd.
12 Hasadna
Or Yehuda,  IL 60200
Correspondent Contact SHARON CHAPLIK
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/02/2010
Decision Date 09/29/2010
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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