zirkon; structure; LFU shades, stains and glazes
K-Number: K251084 · 2025-06-05
ApplicantEstetic Ceram AG
Decision Date2025-06-05
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
zirkon; structure; LFU shades, stains and glazes is a medical device manufactured by Estetic Ceram AG. It received FDA 510(k) clearance on 2025-06-05 under approval number K251084. 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 zirkon; structure; LFU shades, stains and glazes?
zirkon; structure; LFU shades, stains and glazes is a medical device that received FDA 510(k) clearance on 2025-06-05. It is manufactured by Estetic Ceram AG. The 510(k) number is K251084.
When was zirkon; structure; LFU shades, stains and glazes approved by the FDA?
zirkon; structure; LFU shades, stains and glazes received FDA 510(k) clearance on 2025-06-05, under approval number K251084.
What company makes zirkon; structure; LFU shades, stains and glazes?
zirkon; structure; LFU shades, stains and glazes is manufactured by Estetic Ceram AG.
What is the FDA product code for zirkon; structure; LFU shades, stains and glazes?
The FDA product code for zirkon; structure; LFU shades, stains and glazes is EIH.
Related Devices (Code: EIH)
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.