FDA 510(k) Application Details - K070991

Device Classification Name Crown And Bridge, Temporary, Resin

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510(K) Number K070991
Device Name Crown And Bridge, Temporary, Resin
Applicant VITA
3150 E.BIRCH ST
BREA, CA 92821 US
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Contact ELIZABETH WOLFSEN
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Regulation Number 872.3770

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Classification Product Code EBG
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Date Received 04/09/2007
Decision Date 06/01/2007
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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