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FDA 510(k) Application Details - K013179
Device Classification Name
Coating, Filling Material, Resin
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.3310
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Classification Product Code
EBD
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More FDA Info for this Product Code
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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