Cleared Traditional

K140491 - TANAKA ZIRCOLOR COLORING LIQUID

K140491 is an FDA 510(k) clearance for TANAKA ZIRCOLOR COLORING LIQUID, manufactured by Tanaka Dental. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 447-day FDA review.

K140491 · Tanaka Dental · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
447d
Days
Class 2
Risk

K140491 is an FDA 510(k) clearance for the TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA EN.... Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Tanaka Dental (Skokie, US). The FDA issued a Cleared decision on May 20, 2015 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Tanaka Dental devices

FDA 510(k) Submission Details - K140491

510(k) Number K140491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2014
Decision Date May 20, 2015
Days to Decision 447 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
320d slower than avg
Panel avg: 127d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

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 291
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