FDA 510(k) Application Details - K062065

Device Classification Name Cement, Dental

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510(K) Number K062065
Device Name Cement, Dental
Applicant SOUTHERN DENTAL INDUSTRIES, INC.
729 N. ROUTE 83, SUITE 315
BENSENVILLE, IL 60106 US
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Contact RAY CAHILL
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 07/20/2006
Decision Date 11/15/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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