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510(k) K090106

PRELUDE ONE by Danville Materials, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2009
Date Received
January 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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