Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Digital X-Ray DentiMax Pro Imaging System

K-Number: K251206 · 2025-09-24

Decision Date2025-09-24
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Digital X-Ray DentiMax Pro Imaging System is a medical device manufactured by Dentimax, Inc.. It received FDA 510(k) clearance on 2025-09-24 under approval number K251206. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital X-Ray DentiMax Pro Imaging System?

Digital X-Ray DentiMax Pro Imaging System is a medical device that received FDA 510(k) clearance on 2025-09-24. It is manufactured by Dentimax, Inc.. The 510(k) number is K251206.

When was Digital X-Ray DentiMax Pro Imaging System approved by the FDA?

Digital X-Ray DentiMax Pro Imaging System received FDA 510(k) clearance on 2025-09-24, under approval number K251206.

What company makes Digital X-Ray DentiMax Pro Imaging System?

Digital X-Ray DentiMax Pro Imaging System is manufactured by Dentimax, Inc..

What is the FDA product code for Digital X-Ray DentiMax Pro Imaging System?

The FDA product code for Digital X-Ray DentiMax Pro Imaging System is MUH.

Related Clinical Trials

Related PubMed Literature

Other Devices by Dentimax, Inc.

Related Devices (Code: MUH)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.