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FDA 510(k)

ZIRCONOMER P

K-Number: K252165 · 2025-10-28

ApplicantShofu Dental Corporation
Decision Date2025-10-28
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZIRCONOMER P is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2025-10-28 under approval 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. It is manufactured by Shofu Dental Corporation. The 510(k) number is K252165.

When was ZIRCONOMER P approved by the FDA?

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

What company makes ZIRCONOMER P?

ZIRCONOMER P is manufactured by Shofu Dental Corporation.

What is the FDA product code for ZIRCONOMER P?

The FDA product code for ZIRCONOMER P is EMA.

Other Devices by Shofu Dental Corporation

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Related Devices (Code: EMA)

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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.

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