FDA 510(k) Application Details - K984248

Device Classification Name Cement, Dental

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510(K) Number K984248
Device Name Cement, Dental
Applicant ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
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Contact ANDREA PETERMANN
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 11/27/1998
Decision Date 01/08/1999
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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