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510(k) K151535

Cavex Cream Alginate by Cavex Holland BV — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2015
Date Received
June 8, 2015
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)
  • K061267 — SIMULATE, COLOR CHANGE ALGINATE (July 10, 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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