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510(k) K120379

PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S by Kuraray Medical, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2012
Date Received
February 7, 2012
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.

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  • 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)
  • K062382 — CLEARFIL DC BOND (September 27, 2006)

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