WILLI GELLER CREATION II PORCELAIN— 510(k) K043468

Name: FDA 510(k) clearance K043468
Creator: U.S. Food and Drug Administration
Published: 2005-01-12

Substantially Equivalent

Jensen Int'L, Inc.

FDA 510(k) clearance K043468 for WILLI GELLER CREATION II PORCELAIN, Substantially Equivalent on 2005-01-12. Applicant: Jensen Int'L, Inc.. Device class: 2.

Clearance details

Applicant: Jensen Int'L, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2004-12-16
Decision date: 2005-01-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

view all

K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30
K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

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