FDA 510(k) Application Details - K100062

Device Classification Name Sealant, Pit And Fissure, And Conditioner

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510(K) Number K100062
Device Name Sealant, Pit And Fissure, And Conditioner
Applicant DMG USA, INC.
23 FRANK MOSSBERG DRIVE
ATTLEBORO, MA 02703 US
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Contact PAMELA PAPINEAU
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Regulation Number 872.3765

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Classification Product Code EBC
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Date Received 01/11/2010
Decision Date 03/26/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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