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FDA 510(k)

CEPHX3D

K-Number: K252538 · 2026-03-05

ApplicantOrca Dental AI , Ltd.
Decision Date2026-03-05
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEPHX3D is a medical device manufactured by Orca Dental AI , Ltd.. It received FDA 510(k) clearance on 2026-03-05 under approval number K252538. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEPHX3D?

CEPHX3D is a medical device that received FDA 510(k) clearance on 2026-03-05. It is manufactured by Orca Dental AI , Ltd.. The 510(k) number is K252538.

When was CEPHX3D approved by the FDA?

CEPHX3D received FDA 510(k) clearance on 2026-03-05, under approval number K252538.

What company makes CEPHX3D?

CEPHX3D is manufactured by Orca Dental AI , Ltd..

What is the FDA product code for CEPHX3D?

The FDA product code for CEPHX3D is QIH.

Other Devices by Orca Dental AI , Ltd.

K231396CEPHX- Cephalometric Analysis Software

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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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