FDA 510(k) Application Details - K033432

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K033432
Device Name Crown And Bridge, Temporary, Resin
Applicant IMTEC CORP.
2401 NORTH COMMERCE
ARDMORE, OK 73401 US
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Contact BRAD VANCE
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 10/28/2003
Decision Date 01/15/2004
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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