FDA 510(k) Application Details - K990763

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

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510(K) Number K990763
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
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Contact ANDREAS PETERMANN
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 03/08/1999
Decision Date 05/25/1999
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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