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510(k) K111975

CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK by Kuraray Medical, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2011
Date Received
July 12, 2011
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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  • K100328 — CLEARFIL MAJETY POSTERIOR (March 5, 2010)
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  • K070325 — CLEARFIL MAJESTY ESTHETIC PLT (March 21, 2007)
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  • K061906 — CLEARFIL CERAMIC PRIMER (September 28, 2006)
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