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FDA 510(k) Application Details - K965060
Device Classification Name
Material, Tooth Shade, Resin
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510(K) Number
K965060
Device Name
Material, Tooth Shade, Resin
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN, UT 84095 US
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Contact
CHESTER MCOY
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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
12/18/1996
Decision Date
01/31/1997
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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