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FDA 510(k) Application Details - K000189
Device Classification Name
Agent, Tooth Bonding, Resin
More FDA Info for this Device
510(K) Number
K000189
Device Name
Agent, Tooth Bonding, Resin
Applicant
ULTRADENT PRODUCTS, INC.
505 WEST 10200 SOUTH
SOUTH JORDAN, UT 84095 US
Other 510(k) Applications for this Company
Contact
SCOTT E MOORE
Other 510(k) Applications for this Contact
Regulation Number
872.3200
More FDA Info for this Regulation Number
Classification Product Code
KLE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/21/2000
Decision Date
05/11/2000
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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