FDA 510(k) Application Details - K994251

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K994251
Device Name Material, Tooth Shade, Resin
Applicant ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
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Contact ANDREAS PETERMANN
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 12/17/1999
Decision Date 01/03/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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