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FDA 510(k)

Amber Mill Q Series & Amber Mill Direct Series

K-Number: K202952 · 2021-08-26

ApplicantHass Corp.
Decision Date2021-08-26
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Amber Mill Q Series & Amber Mill Direct Series is the device name listed in this FDA 510(k) record. The listed applicant is Hass Corp.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K202952. 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 Mill Q Series & Amber Mill Direct Series?

Amber Mill Q Series & Amber Mill Direct Series is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Hass Corp.. The 510(k) number is K202952.

When did Amber Mill Q Series & Amber Mill Direct Series receive FDA 510(k) clearance?

Amber Mill Q Series & Amber Mill Direct Series received FDA 510(k) clearance on 2021-08-26, under 510(k) number K202952.

Who is the listed applicant for Amber Mill Q Series & Amber Mill Direct Series?

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 Mill Q Series & Amber Mill Direct Series?

The FDA product code for Amber Mill Q Series & Amber Mill Direct Series is EIH.

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 SPK160102Amber Mill Series and Amber Press Series

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.

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.K253191DCMhotbond zirconDental Creativ Management GmbH

Official Source

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

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