Cleared Abbreviated

K100232 - LUMINESSE ZR BLANKS

K100232 is an FDA 510(k) clearance for LUMINESSE ZR BLANKS, manufactured by Talladium, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 115-day FDA review.

K100232 · Talladium, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
115d
Days
Class 2
Risk

K100232 is an FDA 510(k) clearance for the LUMINESSE ZR BLANKS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Talladium, Inc. (Valencia, US). The FDA issued a Cleared decision on May 21, 2010 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K100232

510(k) Number K100232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date May 21, 2010
Days to Decision 115 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 128d · This submission: 115d
Pathway characteristics
Standards-based clearance path.

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 487
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K100232.
VITABLOCS
K102128 · Vita Zahnfabrik H.Rauter GmbH & Co. · Aug 2010
OBSIDIAN CERAMIC BLOCKS
K100781 · Prismatik Dentalcraft, Inc. · Jun 2010
CERAMICS2IN1
K100150 · Biodenta Swiss AG · May 2010
A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06
K100145 · A&E Bioceramic Co., Ltd. · Apr 2010
XCERAM
K100250 · Xceramusa · Apr 2010
ZR DENTAL BLOCK
K093571 · Ams Co., Ltd. · Mar 2010
K100232 · LUMINESSE ZR BLANKS
Download PDF FDA Summary Talladium, Inc.