Zirconia Collective 4Y Dental Zirconia Blank— 510(k) K262685

Name: FDA 510(k) clearance K262685
Creator: U.S. Food and Drug Administration
Published: 2026-10-30

Substantially Equivalent

Zirconia Collective, Inc.

FDA 510(k) clearance K262685 for Zirconia Collective 4Y Dental Zirconia Blank, Substantially Equivalent on 2026-10-30. Applicant: Zirconia Collective, Inc.. Device class: 2.

Clearance details

Applicant: Zirconia Collective, Inc.
Product code: Product code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2026-07-31
Decision date: 2026-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

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K262756 — Zirconia Dental Ceramics and Staining Solution2026-10-29
K262980 — INNI-CERA (BCM-W500, BCM-W1000)2026-10-21
K262523 — Amber Arte2026-10-16
K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30

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