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FDA 510(k)

Prettau, ICE, Z-White zirconia blanks

K-Number: K183304 · 2019-04-04

ApplicantZirkonzahn Srl
Decision Date2019-04-04
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Prettau, ICE, Z-White zirconia blanks is the device name listed in this FDA 510(k) record. The listed applicant is Zirkonzahn Srl. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K183304. 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 Prettau, ICE, Z-White zirconia blanks?

Prettau, ICE, Z-White zirconia blanks is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Zirkonzahn Srl. The 510(k) number is K183304.

When did Prettau, ICE, Z-White zirconia blanks receive FDA 510(k) clearance?

Prettau, ICE, Z-White zirconia blanks received FDA 510(k) clearance on 2019-04-04, under 510(k) number K183304.

Who is the listed applicant for Prettau, ICE, Z-White zirconia blanks?

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

What is the FDA product code for Prettau, ICE, Z-White zirconia blanks?

The FDA product code for Prettau, ICE, Z-White zirconia blanks is EIH.

Other records listing Zirkonzahn Srl 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.

K232691PolibondK213722ICE Ceramics, ICE Stains, FrescoK203765ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-TrayK200676ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPAK190518Color Liquid, Vita LiquidK181484Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

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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

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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