IMPRESSIX— 510(k) K052455

Substantially Equivalent

Cavex Holland BV

FDA 510(k) clearance K052455 for IMPRESSIX, Substantially Equivalent on 2005-11-23. Applicant: Cavex Holland BV. Device class: 2.

Clearance details

Applicant: Cavex Holland BV
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2005-09-07
Decision date: 2005-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haarlem, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELW

K254142 — Dia-X Sil Heavy Body2026-09-16
K254152 — Dia-X Sil Light Body2026-09-16
K254112 — Dia-X Sil Bite2026-03-19
K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more2025-10-31
K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2025-06-27

More clearances from Cavex Holland BV

K151535 — Cavex Cream Alginate2015-10-28
K141092 — MARK32014-12-04
K073539 — PROVISA CEM2008-01-31
K072245 — EMULATE ADVANCED2007-11-08
K062400 — IMPRESSIX, COLORCHANGE ALGINATE2006-11-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.