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FDA 510(k) Application Details - K971899
Device Classification Name
Resin, Root Canal Filling
More FDA Info for this Device
510(K) Number
K971899
Device Name
Resin, Root Canal Filling
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN, UT 84095 US
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Contact
CHESTER MCCOY
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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
05/22/1997
Decision Date
06/26/1997
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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