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FDA 510(k) Application Details - K970246
Device Classification Name
Material, Tooth Shade, Resin
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510(K) Number
K970246
Device Name
Material, Tooth Shade, Resin
Applicant
KAROLINSKI
KUNGSTENSGATAN 56NB
S-113 29
STOCKHOLM SE
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Contact
SVEN LINDSKOG
Other 510(k) Applications for this Contact
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
01/21/1997
Decision Date
04/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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