LUXER SHADED ZIRCONIA— 510(k) K140070

Name: FDA 510(k) clearance K140070
Creator: U.S. Food and Drug Administration
Published: 2014-05-07

Substantially Equivalent

Continental Dental Ceramics, Inc.

FDA 510(k) clearance K140070 for LUXER SHADED ZIRCONIA, Substantially Equivalent on 2014-05-07. Applicant: Continental Dental Ceramics, Inc.. Device class: 2.

Clearance details

Applicant: Continental Dental Ceramics, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2014-01-13
Decision date: 2014-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

view all

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

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