ERIS LAYERING MATERIALS— 510(k) K012174

Name: FDA 510(k) clearance K012174
Creator: U.S. Food and Drug Administration
Published: 2001-08-27

Substantially Equivalent

Ivoclar North America, Inc.

FDA 510(k) clearance K012174 for ERIS LAYERING MATERIALS, Substantially Equivalent on 2001-08-27. Applicant: Ivoclar North America, Inc.. Device class: 2.

Clearance details

Applicant: Ivoclar North America, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2001-07-12
Decision date: 2001-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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

More clearances from Ivoclar North America, Inc.

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K011491 — HELIOSEAL CLEAR CHROMA2001-08-16
K011492 — IN TEN-S2001-07-05
K011490 — MODIFICATION TO EXCITE2001-06-27
K011022 — BIOUNIVERSAL PDF2001-05-02
K011023 — D.SIGN 962001-05-02

Recalls naming K012174

K-number listed on FDA's recall record

Z-2265-2015 — IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorationsClass II·Terminated·Ivoclar Vivadent, Inc.·20150709

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012174.

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