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510(k) K061267

SIMULATE, COLOR CHANGE ALGINATE by Cavex Holland BV — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2006
Date Received
May 5, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

Other clearances by Cavex Holland BV

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  • K062400 — IMPRESSIX, COLORCHANGE ALGINATE (November 16, 2006)
  • K052455 — IMPRESSIX (November 23, 2005)
  • K051207 — CAVEX ORTHOTRACE (June 21, 2005)
  • K042806 — QUADRANT UNIT-1-BOND (November 24, 2004)
  • K032116 — TULIP COLORSWITCH (September 30, 2003)
  • K023466 — TULIP ALGINATE IMPRESSION MATERIAL (December 13, 2002)

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