Cleared Abbreviated

K183408 - Jensen Shade Effect Liquids

K183408 is the FDA 510(k) clearance for Jensen Shade Effect Liquids by Jensen Industries, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Abbreviated 510(k) pathway after a 100-day FDA review.

K183408 · Jensen Industries, Inc. · Dental device
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Mar 2019
Decision
100d
Days
Class 2
Risk

K183408 is an FDA 510(k) clearance for the Jensen Shade Effect Liquids. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Jensen Industries, Inc. (North Haven, US). The FDA issued a Cleared decision on March 20, 2019 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Jensen Industries, Inc. devices

Submission Details

510(k) Number K183408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2018
Decision Date March 20, 2019
Days to Decision 100 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 127d · This submission: 100d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EIH Powder, Porcelain

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