FDA 510(k) Application Details - K073209

Device Classification Name Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief

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510(K) Number K073209
Device Name Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Applicant KERR CORPORATION
1717 WEST COLLINS AVE.
ORANGE, CA 92867 US
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Contact COLLEEN BOSWELL
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Regulation Number 872.3275

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Classification Product Code MZW
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Date Received 11/14/2007
Decision Date 01/29/2008
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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