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FDA 510(k)

Franz Zirconia Dental Crown

K-Number: K203072 · 2022-01-19

ApplicantFranz Biotech, Inc.
Decision Date2022-01-19
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Franz Zirconia Dental Crown is the device name listed in this FDA 510(k) record. The listed applicant is Franz Biotech, Inc.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K203072. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Franz Zirconia Dental Crown?

Franz Zirconia Dental Crown is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Franz Biotech, Inc.. The 510(k) number is K203072.

When did Franz Zirconia Dental Crown receive FDA 510(k) clearance?

Franz Zirconia Dental Crown received FDA 510(k) clearance on 2022-01-19, under 510(k) number K203072.

Who is the listed applicant for Franz Zirconia Dental Crown?

The FDA 510(k) record lists Franz Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Franz Zirconia Dental Crown?

The FDA product code for Franz Zirconia Dental Crown is ELL.

Related Clinical Trials

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.

NCT04695899Zirconia Implants for Replacement of a Single ToothACTIVE_NOT_RECRUITINGNCT07672470Parent Satisfaction With Zirconia, Bioflx, and 3D-Printed Crowns for Primary MolarsACTIVE_NOT_RECRUITING

Related Devices (Code: ELL)

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.

K240586Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd.K162043NobelProcera HT ML FCZ BridgeNobel Biocare ABK153534NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare AB

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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