Cleared Traditional

K152066 - Luminesse Anterior Zirconia AT

K152066 is the FDA 510(k) clearance for Luminesse Anterior Zirconia AT by Talladium, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K152066 · Talladium, Inc. · Dental device
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Oct 2015
Decision
89d
Days
Class 2
Risk

K152066 is an FDA 510(k) clearance for the Luminesse Anterior Zirconia AT. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Talladium, Inc. (Valencia, US). The FDA issued a Cleared decision on October 21, 2015 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Talladium, Inc. devices

Submission Details

510(k) Number K152066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2015
Decision Date October 21, 2015
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 253
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K152066.
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BruxZir Anterior
K143330 · Prismatik Dentalcraft, Inc. · Dec 2014