FDA.reportPublic FDA data

ORCA DENTAL AI

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30306554343030655434ORCA DENTAL AI1N2026-01-015, Hatidhar Ra'anana Central IL 4366507

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07290019703006CEPHX- CEPHALOMETRIC ANALYSIS SOFTWARE - CephX is a standalone software device intended for use by dental and orthodontic professionals for the viewing, analysis, and measurement of 2D cephalometric x-ray images. The software provides automated tracing, anatomical landmark detection, and treatment planning tools to assist clinicians in orthodontic evaluation.+972538789977support@cephx.com
07290019703013CEPHX3D - 1.00+975538789977support@cephx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3261341974825676K252538CEPHX3DQIH2026-03-05
3261341188409834K231396CEPHX- Cephalometric Analysis SoftwareLLZ2024-01-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QIH12026-03-05
LLZ12024-01-31

PMN#

GUDID#