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FDA 510(k) Application Details - K982692
Device Classification Name
Material, Tooth Shade, Resin
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510(K) Number
K982692
Device Name
Material, Tooth Shade, Resin
Applicant
STERNGOLD/IMPLAMED
50 BREWSTER ST.
PAWTUCKET, RI 02860 US
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Contact
PAMELA PAPINEAU
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Regulation Number
872.3690
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Classification Product Code
EBF
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More FDA Info for this Product Code
Date Received
08/03/1998
Decision Date
10/22/1998
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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