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FDA 510(k)

CEPHX- Cephalometric Analysis Software

K-Number: K231396 · 2024-01-31

ApplicantOrca Dental AI , Ltd.
Decision Date2024-01-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CEPHX- Cephalometric Analysis Software 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 2024-01-31 under 510(k) number K231396. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEPHX- Cephalometric Analysis Software?

CEPHX- Cephalometric Analysis Software is a medical device that received FDA 510(k) clearance on 2024-01-31. The listed applicant is Orca Dental AI , Ltd.. The 510(k) number is K231396.

When did CEPHX- Cephalometric Analysis Software receive FDA 510(k) clearance?

CEPHX- Cephalometric Analysis Software received FDA 510(k) clearance on 2024-01-31, under 510(k) number K231396.

Who is the listed applicant for CEPHX- Cephalometric Analysis Software?

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 CEPHX- Cephalometric Analysis Software?

The FDA product code for CEPHX- Cephalometric Analysis Software is LLZ.

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.

K252538CEPHX3D

Related Devices (Code: LLZ)

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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.

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