Cleared Traditional

K140491 - TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
319d slower than avg
Panel avg: 128d · 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 471
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K140491.
Nacera Pearl
K143071 · Doceram Medical Ceramics GmbH · Jun 2015
ZIBONE ZIRCONIA BLOCKS
K140836 · Coho Technology Co., Ltd. · Jun 2015
LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
K143090 · Talladium, Inc. · Jun 2015
Luxisse+
K150056 · Heany Industries, Inc. · May 2015
DD cubeX2
K150196 · Dental Direkt GmbH · Mar 2015
KATANA Zirconia
K143439 · Kuraray Noritake Dental, Inc. · Feb 2015