K-number	K251030
Device name	Sirona Advanced Imaging Suite
Applicant	Sirona Medical
Product code	LLZ
Device class	Class II
Decision date	Oct 22, 2025
Decision	Substantially Equivalent
Regulation	892.2050

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Sirona Advanced Imaging Suite

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