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FDA 510(k)

Dental Zirconia Ceramic

K-Number: K250811 · 2025-04-11

ApplicantAidite (Qinhuangdao) Technology Co., Ltd.
Decision Date2025-04-11
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Zirconia Ceramic is a medical device manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under approval number K250811. 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 Dental Zirconia Ceramic?

Dental Zirconia Ceramic is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K250811.

When was Dental Zirconia Ceramic approved by the FDA?

Dental Zirconia Ceramic received FDA 510(k) clearance on 2025-04-11, under approval number K250811.

What company makes Dental Zirconia Ceramic?

Dental Zirconia Ceramic is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd..

What is the FDA product code for Dental Zirconia Ceramic?

The FDA product code for Dental Zirconia Ceramic is EIH.

Related Clinical Trials

NCT06012071 Two-piece Zirconia Implants With Two Various Platforms RECRUITING NCT01974362 Monolithic Zirconia Full-Mouth Implant Supported Rehabilitation Behavior RECRUITING NCT03908177 Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT. COMPLETED NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING NCT07521501 Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design NOT_YET_RECRUITING NCT07500636 Long-Term Periodontal Tissue Changes Associated With Metal-Ceramic Crowns: An 8-Year Split-Mouth Study COMPLETED

Other Devices by Aidite (Qinhuangdao) Technology Co., Ltd.

K190217Aidite PMMA K192723Coloring Liquid K192231Dental Glass Ceramics Blocks K222626Dental Zirconia Ceramic K213570Dental Zirconia Ceramic K230115Denture Base Resin

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Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160203ADAMANT ZIRCONIA DISCAdamant Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, Inc.

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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