FDA 510(k) Application Details - K101869

Device Classification Name Cement, Dental

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510(K) Number K101869
Device Name Cement, Dental
Applicant SILMET LTD.
12 HASADNA
OR YEHUDA 60200 IL
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Contact SHARON CHAPLIK
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 07/02/2010
Decision Date 09/29/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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