Home / 510(k) Clearances / K052455

510(k) K052455

IMPRESSIX by Cavex Holland BV — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2005
Date Received
September 7, 2005
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

  • K151535 — Cavex Cream Alginate (October 28, 2015)
  • K141092 — MARK3 (December 4, 2014)
  • K073539 — PROVISA CEM (January 31, 2008)
  • K072245 — EMULATE ADVANCED (November 8, 2007)
  • K062400 — IMPRESSIX, COLORCHANGE ALGINATE (November 16, 2006)
  • K061267 — SIMULATE, COLOR CHANGE ALGINATE (July 10, 2006)
  • 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)

Other clearances for product code ELW

  • K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular (October 31, 2025)
  • K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (June 27, 2025)
  • K241924 — Elastic Impression Material (December 27, 2024)
  • K242360 — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex U (November 15, 2024)
  • K233954 — Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu (February 13, 2024)
  • K223892 — DentMix VPS Impression Material (April 27, 2023)
  • K213175 — No Stress Impress (January 19, 2023)
  • K214086 — Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impres (December 15, 2022)
  • K222741 — DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(R (November 7, 2022)
  • K213244 — Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Ac (September 9, 2022)