FDA 510(k) Application Details - K013179

Device Classification Name Coating, Filling Material, Resin

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510(K) Number K013179
Device Name Coating, Filling Material, Resin
Applicant DMG USA, INC.
414 SOUTH STATE ST.
DOVER, DE 19901 US
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Contact PAMELA PAPINEAU
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Regulation Number 872.3310

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Classification Product Code EBD
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Date Received 09/24/2001
Decision Date 10/12/2001
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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