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FDA 510(k)

CEPHX3D

K-Number: K252538 · 2026-03-05

Decision Date2026-03-05
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEPHX3D is the device name listed in this FDA 510(k) record. The listed applicant is Orca Dental AI , Ltd.. It received FDA 510(k) clearance on 2026-03-05 under 510(k) 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. The listed applicant is Orca Dental AI , Ltd.. The 510(k) number is K252538.

When did CEPHX3D receive FDA 510(k) clearance?

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

Who is the listed applicant for CEPHX3D?

The FDA 510(k) record lists Orca Dental AI , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEPHX3D?

The FDA product code for CEPHX3D is QIH.

Other records listing Orca Dental AI , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.