Zirconia Dental Ceramics and Staining Solution— 510(k) K262756

Name: FDA 510(k) clearance K262756
Creator: U.S. Food and Drug Administration
Published: 2026-10-29

Substantially Equivalent

Fanen New Materials Technology (Suzhou) Co., Ltd.

FDA 510(k) clearance K262756 for Zirconia Dental Ceramics and Staining Solution, Substantially Equivalent on 2026-10-29. Applicant: Fanen New Materials Technology (Suzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Fanen New Materials Technology (Suzhou) Co., Ltd.
Product code: Product code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2026-08-03
Decision date: 2026-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

view all

K262685 — Zirconia Collective 4Y Dental Zirconia Blank2026-10-30
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.