Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZircaGlow & ZircaGlow HT Zirconia

K-Number: K250393 · 2025-05-12

ApplicantUnited Zirconia
Decision Date2025-05-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZircaGlow & ZircaGlow HT Zirconia is a medical device manufactured by United Zirconia. It received FDA 510(k) clearance on 2025-05-12 under approval number K250393. 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 ZircaGlow & ZircaGlow HT Zirconia?

ZircaGlow & ZircaGlow HT Zirconia is a medical device that received FDA 510(k) clearance on 2025-05-12. It is manufactured by United Zirconia. The 510(k) number is K250393.

When was ZircaGlow & ZircaGlow HT Zirconia approved by the FDA?

ZircaGlow & ZircaGlow HT Zirconia received FDA 510(k) clearance on 2025-05-12, under approval number K250393.

What company makes ZircaGlow & ZircaGlow HT Zirconia?

ZircaGlow & ZircaGlow HT Zirconia is manufactured by United Zirconia.

What is the FDA product code for ZircaGlow & ZircaGlow HT Zirconia?

The FDA product code for ZircaGlow & ZircaGlow HT Zirconia is EIH.

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.

↑