Name: Predicase
Price: 199 USD

K-number	K251842
Device name	Dental Computed Tomography X-ray System
Applicant	Fussen Technology Co., Ltd.
Product code	OAS
Device class	Class II
Decision date	Nov 13, 2025
Decision	Substantially Equivalent
Regulation	892.1750

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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Dental Computed Tomography X-ray System

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