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FDA 510(k)

Amber Mill Series and Amber Press Series

K-Number: K160102 · 2016-07-14

ApplicantHass Corp.
Decision Date2016-07-14
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Amber Mill Series and Amber Press 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 2016-07-14 under 510(k) number K160102. 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 Series and Amber Press Series?

Amber Mill Series and Amber Press Series is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Hass Corp.. The 510(k) number is K160102.

When did Amber Mill Series and Amber Press Series receive FDA 510(k) clearance?

Amber Mill Series and Amber Press Series received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160102.

Who is the listed applicant for Amber Mill Series and Amber Press 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 Series and Amber Press Series?

The FDA product code for Amber Mill Series and Amber Press 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 SPK202952Amber Mill Q Series & Amber Mill Direct 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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