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FDA 510(k)

Digital X-Ray DentiMax Pro Imaging System

K-Number: K251206 · 2025-09-24

ApplicantDentimax, Inc.
Decision Date2025-09-24
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Digital X-Ray DentiMax Pro Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Dentimax, Inc.. It received FDA 510(k) clearance on 2025-09-24 under 510(k) 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. The listed applicant is Dentimax, Inc.. The 510(k) number is K251206.

When did Digital X-Ray DentiMax Pro Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for Digital X-Ray DentiMax Pro Imaging System?

The FDA 510(k) record lists Dentimax, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Dentimax, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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