COPRANCOLOR— 510(k) K123680

Name: FDA 510(k) clearance K123680
Creator: U.S. Food and Drug Administration
Published: 2013-02-21

Substantially Equivalent

White Peaks Dental Systems GmbH & Co. KG

FDA 510(k) clearance K123680 for COPRANCOLOR, Substantially Equivalent on 2013-02-21. Applicant: White Peaks Dental Systems GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: White Peaks Dental Systems GmbH & Co. KG
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2012-11-30
Decision date: 2013-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Essen, DE

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

More clearances from White Peaks Dental Systems GmbH & Co. KG

view all

K131664 — COPRA TEMP PMMA-DISK2013-12-18
K092496 — COPRAN ZR/ORIGIN YZ2009-09-18

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