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Digital X-Ray DentiMax Pro Imaging System

by Dentimax, Inc.

510(k) K251206

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251206 Date24 Sep 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MUH
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Digital X-Ray DentiMax Pro Imaging System is a digital extraoral X-ray system intended for dental imaging. It is classified as a Class II medical device under regulation number 872.1800 and product code MUH.

The system received FDA 510(k) clearance (K251206) on September 24, 2025, as substantially equivalent to a predicate device. It is manufactured by Dentimax, Inc. and is intended for use in dental clinical settings.

Other devices from Dentimax

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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

    The Digital X-Ray DentiMax Pro Imaging System is intended for dental imaging as a digital extraoral X-ray system, designed for use in dental clinical settings to capture radiographic images of the teeth and surrounding structures.

  • How is the Digital X-Ray DentiMax Pro Imaging System supplied and is it reusable?

    The system is supplied as a complete digital extraoral X-ray imaging system, including hardware and software components necessary for image acquisition and processing; it is designed for repeated use in clinical environments and is not a single-use device.

  • What regulatory pathway was used for the Digital X-Ray DentiMax Pro Imaging System and when was it cleared?

    The system received FDA 510(k) clearance under submission number K251206 on September 24, 2025, as substantially equivalent to a legally marketed predicate device, and is classified as a Class II medical device under regulation 872.1800 with product code MUH.