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FDA 510(k)

Amber Arte

K-Number: K262523 · 2026-10-16

ApplicantHass Corp.
Decision Date2026-10-16
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Amber Arte is the device name listed in this FDA 510(k) record. The listed applicant is Hass Corp.. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K262523. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Amber Arte?

Amber Arte is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is Hass Corp.. The 510(k) number is K262523.

When did Amber Arte receive FDA 510(k) clearance?

Amber Arte received FDA 510(k) clearance on 2026-10-16, under 510(k) number K262523.

Who is the listed applicant for Amber Arte?

The FDA 510(k) record lists Hass Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amber Arte?

The FDA product code for Amber Arte is EIH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Hass Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260859Rosetta SM, Rosetta SPK202952Amber Mill Q Series & Amber Mill Direct SeriesK160102Amber Mill Series and Amber Press SeriesK111573MONOBLOC BM SERIESK102305HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P

Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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