NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN— 510(k) K030859

Name: FDA 510(k) clearance K030859
Creator: U.S. Food and Drug Administration
Published: 2003-03-27

Substantially Equivalent

Enamelite, LLC

FDA 510(k) clearance K030859 for NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN, Substantially Equivalent on 2003-03-27. Applicant: Enamelite, LLC. Device class: 2.

Clearance details

Applicant: Enamelite, LLC
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2003-03-18
Decision date: 2003-03-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Clarksville, TN, 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 Enamelite, LLC

view all

K093019 — ENAMELITE ACRYSEAL SPRAY SEALANT2009-12-22

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