Amber Arte— 510(k) K262523

Substantially Equivalent

Hass Corp.

FDA 510(k) clearance K262523 for Amber Arte, Substantially Equivalent on 2026-10-16. Applicant: Hass Corp.. Device class: 2.

Clearance details

Applicant: Hass Corp.
Product code: Product code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2026-07-22
Decision date: 2026-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gangneung, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

K262685 — Zirconia Collective 4Y Dental Zirconia Blank2026-10-30
K262756 — Zirconia Dental Ceramics and Staining Solution2026-10-29
K262980 — INNI-CERA (BCM-W500, BCM-W1000)2026-10-21
K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30

More clearances from Hass Corp.

K260859 — Rosetta SM, Rosetta SP2026-06-11
K202952 — Amber Mill Q Series & Amber Mill Direct Series2021-08-26
K160102 — Amber Mill Series and Amber Press Series2016-07-14
K111573 — MONOBLOC BM SERIES2011-08-26
K102305 — HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P2010-12-03

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