PRISMATIK CLINICAL ZIRCONIA— 510(k) K060104

Name: FDA 510(k) clearance K060104
Creator: U.S. Food and Drug Administration
Published: 2006-03-15

Substantially Equivalent

Glidewell Laboratories

FDA 510(k) clearance K060104 for PRISMATIK CLINICAL ZIRCONIA, Substantially Equivalent on 2006-03-15. Applicant: Glidewell Laboratories. Device class: 2.

Clearance details

Applicant: Glidewell Laboratories
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2006-01-13
Decision date: 2006-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, 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

More clearances from Glidewell Laboratories

view all

K050144 — PRISMATIK CERAMIC2005-03-03
K972424 — SILENTNITE1997-09-18

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