Cleared Traditional

K143090 - LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID

K143090 is an FDA 510(k) clearance for LUMINESSE PRE-SINTERED ZIRCONIA COLORIN..., manufactured by Talladium, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K143090 · Talladium, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
230d
Days
Class 2
Risk

K143090 is an FDA 510(k) clearance for the LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Talladium, Inc. (Valencia, US). The FDA issued a Cleared decision on June 15, 2015 after a review of 230 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Talladium, Inc. devices

FDA 510(k) Submission Details - K143090

510(k) Number K143090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2014
Decision Date June 15, 2015
Days to Decision 230 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
103d slower than avg
Panel avg: 127d · This submission: 230d
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 400
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K143090.
BruxZir Anterior Milling Blanks
K150872 · Prismatik Dentalcraft, Inc. · Jul 2015
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K143071 · Doceram Medical Ceramics GmbH · Jun 2015
ZIBONE ZIRCONIA BLOCKS
K140836 · Coho Technology Co., Ltd. · Jun 2015
TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS
K140491 · Tanaka Dental · May 2015
Luxisse+
K150056 · Heany Industries, Inc. · May 2015
DD cubeX2
K150196 · Dental Direkt GmbH · Mar 2015