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FDA 510(k) Application Details - K992097
Device Classification Name
Resin, Root Canal Filling
More FDA Info for this Device
510(K) Number
K992097
Device Name
Resin, Root Canal Filling
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN, UT 84095 US
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Contact
SCOTT E MOORE
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Regulation Number
872.3820
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Classification Product Code
KIF
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More FDA Info for this Product Code
Date Received
06/21/1999
Decision Date
10/26/1999
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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