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510(k) K111980

CLEARFIL TRI-S BOND PLUS by Kuraray America, 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

Other clearances by Kuraray America, Inc.

  • K111982 — CLEARFIL DC CORE PLUS (November 17, 2011)
  • K063595 — CLEARFIL MAJESTY POSTERIOR (February 9, 2007)
  • K063593 — CLEARFIL MAJESTY FLOW (February 2, 2007)
  • K063228 — SURFACE COAT (December 8, 2006)
  • K002322 — MODIFICATION TO PANAVIA F (September 18, 2000)
  • K983361 — PANAVIA F (November 13, 1998)
  • K982259 — CHROMA ZONE COLOR STAIN (September 22, 1998)
  • K982164 — ESTENIA (August 10, 1998)
  • K974486 — CLEARFIL LINER BOND 2V (January 29, 1998)
  • K974089 — ALLOY PRIMER (December 17, 1997)

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