FDA 510(k)

Franz Zirconia Dental Crown

K-Number: K203072 · 2022-01-19

Decision Date2022-01-19

Product CodeELL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Franz Zirconia Dental Crown is a medical device manufactured by Franz Biotech, Inc.. It received FDA 510(k) clearance on 2022-01-19 under approval 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. It is manufactured by Franz Biotech, Inc.. The 510(k) number is K203072.

When was Franz Zirconia Dental Crown approved by the FDA?

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

What company makes Franz Zirconia Dental Crown?

Franz Zirconia Dental Crown is manufactured by Franz Biotech, Inc..

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

NCT07562607 Clinical Evaluation of AI-Generated Dental Crowns ACTIVE_NOT_RECRUITING NCT07541976 Comparative Evaluation of Three Different Pulpotomy Agents in Primary Molars ACTIVE_NOT_RECRUITING NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING NCT07500636 Long-Term Periodontal Tissue Changes Associated With Metal-Ceramic Crowns: An 8-Year Split-Mouth Study COMPLETED

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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.