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FDA 510(k)

DD Hybridlayer (multicolored zirconia)

K-Number: K241579 · 2024-09-06

ApplicantDental Direkt GmbH
Decision Date2024-09-06
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DD Hybridlayer (multicolored zirconia) is the device name listed in this FDA 510(k) record. The listed applicant is Dental Direkt GmbH. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K241579. 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 DD Hybridlayer (multicolored zirconia)?

DD Hybridlayer (multicolored zirconia) is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Dental Direkt GmbH. The 510(k) number is K241579.

When did DD Hybridlayer (multicolored zirconia) receive FDA 510(k) clearance?

DD Hybridlayer (multicolored zirconia) received FDA 510(k) clearance on 2024-09-06, under 510(k) number K241579.

Who is the listed applicant for DD Hybridlayer (multicolored zirconia)?

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

What is the FDA product code for DD Hybridlayer (multicolored zirconia)?

The FDA product code for DD Hybridlayer (multicolored zirconia) is EIH.

Other records listing Dental Direkt GmbH as applicant

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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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