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FDA 510(k)

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

K-Number: K180252 · 2018-04-24

ApplicantCrown Porcelain Dental Technology Co., Ltd.
Decision Date2018-04-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is a medical device manufactured by Crown Porcelain Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-04-24 under approval number K180252. 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 Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank?

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2018-04-24. It is manufactured by Crown Porcelain Dental Technology Co., Ltd.. The 510(k) number is K180252.

When was Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank approved by the FDA?

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2018-04-24, under approval number K180252.

What company makes Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank?

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is manufactured by Crown Porcelain Dental Technology Co., Ltd..

What is the FDA product code for Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank?

The FDA product code for Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is EIH.

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

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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