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FDA 510(k) Application Details - K000954
Device Classification Name
Agent, Tooth Bonding, Resin
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510(K) Number
K000954
Device Name
Agent, Tooth Bonding, Resin
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE, CA 92867 US
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Contact
ORLANDO TADEO, JR.
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Regulation Number
872.3200
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Classification Product Code
KLE
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More FDA Info for this Product Code
Date Received
03/24/2000
Decision Date
04/28/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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