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FDA 510(k) Application Details - K100062
Device Classification Name
Sealant, Pit And Fissure, And Conditioner
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.3765
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Classification Product Code
EBC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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