FDA 510(k) Application Details - K012354

Device Classification Name Post, Root Canal

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510(K) Number K012354
Device Name Post, Root Canal
Applicant DANVILLE MATERIALS, INC.
2021 OMEGA DR.
SAN RAMON, CA 94583 US
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Contact CRAIG R BRUNS
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Regulation Number 872.3810

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Classification Product Code ELR
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Date Received 07/25/2001
Decision Date 10/10/2001
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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