LUMINESSE ZR BLANKS— 510(k) K100232

Substantially Equivalent

Talladium, Inc.

FDA 510(k) clearance K100232 for LUMINESSE ZR BLANKS, Substantially Equivalent on 2010-05-21. Applicant: Talladium, Inc.. Device class: 2.

Clearance details

Applicant: Talladium, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2010-01-26
Decision date: 2010-05-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30
K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

More clearances from Talladium, Inc.

K152023 — Luminesse Shaded Zirconia SZ2016-09-15
K152066 — Luminesse Anterior Zirconia AT2015-10-21
K143090 — LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID2015-06-15
K142371 — Luminesse PMMA2015-04-24
K140848 — LUMINESSE PORCELAIN SYSTEM2014-12-17

Recalls naming K100232

K-number listed on FDA's recall record

Z-2943-2020 — Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.Class II·Terminated·Talladium Inc·20200806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100232.

Data sourced from openFDA. This site is unofficial and independent of the FDA.