FDA 510(k) Application Details - K992067

Device Classification Name Coating, Filling Material, Resin

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510(K) Number K992067
Device Name Coating, Filling Material, Resin
Applicant KERR DENTAL MATERIALS CENTER
1717 WEST COLLINS AVE.
ORANGE, CA 92867 US
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Contact COLLEEN BOSWELL
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Regulation Number 872.3310

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Classification Product Code EBD
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Date Received 06/18/1999
Decision Date 08/27/1999
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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