Cleared Abbreviated

K183408 - Jensen Shade Effect Liquids (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K183408 · Jensen Industries, Inc. · Dental device
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.

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
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 158d · 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

All 31
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