FDA 510(k) Application Details - K080556

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K080556
Device Name Crown And Bridge, Temporary, Resin
Applicant MERZ DENTAL GMBH
5616 MARIOLA PL NE
ALBUQUERQUE, NM 87111 US
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Contact RICHARD G HUNTER, M.S., RAC
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 02/28/2008
Decision Date 05/02/2008
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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