FDA 510(k) Application Details - K061809

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K061809
Device Name Crown And Bridge, Temporary, Resin
Applicant MERZ DENTAL GMBH
4235 PROVIDENCE LN
TUCKER, GA 30084 US
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Contact RICHARD G HUNTER
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 06/27/2006
Decision Date 09/13/2006
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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