K-number	K231396
Device name	CEPHX- Cephalometric Analysis Software
Applicant	Orca Dental AI , Ltd.
Product code	LLZ
Device class	Class II
Decision date	Jan 31, 2024
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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CEPHX- Cephalometric Analysis Software

Everything you need for a 510(k) submission. Nothing you don't.