Jensen Shade Effect Liquids— 510(k) K183408

Name: FDA 510(k) clearance K183408
Creator: U.S. Food and Drug Administration
Published: 2019-03-20

Substantially Equivalent

Jensen Industries, Inc.

FDA 510(k) clearance K183408 for Jensen Shade Effect Liquids, Substantially Equivalent on 2019-03-20. Applicant: Jensen Industries, Inc.. Device class: 2.

Clearance details

Applicant: Jensen Industries, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2018-12-10
Decision date: 2019-03-20
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

More clearances from Jensen Industries, Inc.

view all

K142043 — INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA2014-12-18
K112806 — JENSEN ZIRCONIA2011-12-01
K111743 — THE INSYNC CERAMIC SYSTEM2011-09-14
K070114 — CREATION CP-ZI PORCELAIN2007-03-01
K050838 — THE LF-P CERAMIC SYSTEM2005-05-04

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