FDA 510(k) Application Details - K073243

Device Classification Name Coating, Filling Material, Resin

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510(K) Number K073243
Device Name Coating, Filling Material, Resin
Applicant RELIANCE ORTHODONTIC PRODUCTS, INC.
1540 WEST THORNDALE AVE.
ITASCA, IL 60143 US
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Contact PAUL GANGE
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Regulation Number 872.3310

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Classification Product Code EBD
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Date Received 11/19/2007
Decision Date 02/08/2008
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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