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510(k) K062410

CLEARFIL ESTHETIC CEMENT & DC BOND by Kuraray Medical, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2006
Date Received
August 17, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Kuraray Medical, Inc.

  • K120378 — PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT H (March 30, 2012)
  • K120379 — PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT A (March 30, 2012)
  • 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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