FDA 510(k)

ZircaGlow & ZircaGlow HT Zirconia

K-번호: K250393 · 2025-05-12

결정일2025-05-12

제품 코드EIH

자문 위원회DE

결정Substantially Equivalent

기기 요약

ZircaGlow & ZircaGlow HT Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is United Zirconia. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K250393. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is United Zirconia. The 510(k) number is K250393.

When did ZircaGlow & ZircaGlow HT Zirconia receive FDA 510(k) clearance?

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

Who is the listed applicant for ZircaGlow & ZircaGlow HT Zirconia?

The FDA 510(k) record lists United Zirconia as the applicant. This does not by itself establish the device manufacturer.

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

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

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ZircaGlow & ZircaGlow HT Zirconia

기기 요약

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관련 임상시험

관련 기기 (코드: EIH)

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