FDA 510(k)

ZIRCONOMER P

K-Number: K252165 · 2025-10-28

Decision Date2025-10-28

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ZIRCONOMER P is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2025-10-28 under 510(k) number K252165. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIRCONOMER P?

ZIRCONOMER P is a medical device that received FDA 510(k) clearance on 2025-10-28. The listed applicant is Shofu Dental Corporation. The 510(k) number is K252165.

When did ZIRCONOMER P receive FDA 510(k) clearance?

ZIRCONOMER P received FDA 510(k) clearance on 2025-10-28, under 510(k) number K252165.

Who is the listed applicant for ZIRCONOMER P?

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

What is the FDA product code for ZIRCONOMER P?

The FDA product code for ZIRCONOMER P is EMA.

Other records listing Shofu Dental Corporation as applicant

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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.