Cleared Traditional

K152023 - Luminesse Shaded Zirconia SZ (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152023 · Talladium, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
422d
Days
Class 2
Risk

K152023 is an FDA 510(k) clearance for the Luminesse Shaded Zirconia SZ. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Talladium, Inc. (Valencia, US). The FDA issued a Cleared decision on September 15, 2016 after a review of 422 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 Talladium, Inc. devices

Submission Details

510(k) Number K152023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2015
Decision Date September 15, 2016
Days to Decision 422 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
295d slower than avg
Panel avg: 127d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 478
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K152023.
Eternal Art Porcelain Powders
K260067 · Shandong Huge Dental Material Corporation · Apr 2026
IPS e.max Zirconia
K253953 · Ivoclar Vivadent, Inc. · Mar 2026
BruxZir® Shaded 16 PLUS
K254283 · Prismatik Dentalcraft, Inc. · Jan 2026
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
K253973 · Liaoning Upcera Co., Ltd. · Jan 2026
Glass Ceramic
K252789 · Shenzhen Xiangtong Co., Ltd. · Dec 2025
BruxZir® NOW
K252446 · Prismatik Dentalcraft, Inc. · Sep 2025