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FDA 510(k)

DD BIO Z AND DD BIO Z - TRANSPA

K-Number: K093748 · 2010-02-24

ApplicantDental Direkt of Amerika UG (Haftungsbeschraenkt)
Decision Date2010-02-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DD BIO Z AND DD BIO Z - TRANSPA is the device name listed in this FDA 510(k) record. The listed applicant is Dental Direkt of Amerika UG (Haftungsbeschraenkt). It received FDA 510(k) clearance on 2010-02-24 under 510(k) number K093748. 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 BIO Z AND DD BIO Z - TRANSPA?

DD BIO Z AND DD BIO Z - TRANSPA is a medical device that received FDA 510(k) clearance on 2010-02-24. The listed applicant is Dental Direkt of Amerika UG (Haftungsbeschraenkt). The 510(k) number is K093748.

When did DD BIO Z AND DD BIO Z - TRANSPA receive FDA 510(k) clearance?

DD BIO Z AND DD BIO Z - TRANSPA received FDA 510(k) clearance on 2010-02-24, under 510(k) number K093748.

Who is the listed applicant for DD BIO Z AND DD BIO Z - TRANSPA?

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

What is the FDA product code for DD BIO Z AND DD BIO Z - TRANSPA?

The FDA product code for DD BIO Z AND DD BIO Z - TRANSPA is EIH.

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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.

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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