FDA 510(k) Application Details - K072273

Device Classification Name Unit, Operative Dental, Accessories

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510(K) Number K072273
Device Name Unit, Operative Dental, Accessories
Applicant TAKARA BELMONT USA, INC.
1129 BLOOMFIELD AVENUE
WEST CALDWELL, NJ 07006 US
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Contact ROBERT SCHIFF
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Regulation Number 872.6640

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Classification Product Code NRD
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Date Received 08/15/2007
Decision Date 12/20/2007
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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