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510(k) K043177

CLEAFIL DC CORE AUTOMIX by Kuraray Medical, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2004
Date Received
November 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Kuraray Medical, Inc.

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  • K111975 — CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK (October 14, 2011)
  • K100328 — CLEARFIL MAJETY POSTERIOR (March 5, 2010)
  • K092281 — CLEARFIL MAJESTY POSTERIOR PLT (October 27, 2009)
  • K081583 — CLEARFIL SA CEMENT (July 28, 2008)
  • K071169 — CLEARFIL MAJESTY POSTERIOR PLT (June 20, 2007)
  • K070325 — CLEARFIL MAJESTY ESTHETIC PLT (March 21, 2007)
  • K062409 — K-ETCHANT GEL (November 8, 2006)
  • K061906 — CLEARFIL CERAMIC PRIMER (September 28, 2006)

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