FDA 510(k) Application Details - K982671

Device Classification Name Alloy, Amalgam

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510(K) Number K982671
Device Name Alloy, Amalgam
Applicant SPECIALITES SEPTODONT
1050 CONNECTICUT AVE. NW
WASHINGTON, DC 20036-5339 US
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Contact PETER S REICHERTZ
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Regulation Number 872.3070

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Classification Product Code EJJ
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Date Received 07/31/1998
Decision Date 10/19/1998
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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