JENSEN ZIRCONIA— 510(k) K112806

Substantially Equivalent

Jensen Industries, Inc.

FDA 510(k) clearance K112806 for JENSEN ZIRCONIA, Substantially Equivalent on 2011-12-01. 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: 2011-09-27
Decision date: 2011-12-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

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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.