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DIMEX 2

by Planmeca Oy

510(k) K000454

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000454 Date31 Mar 2000ClearedStatusActive

Official records

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  • Withdrawn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.

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth.

The DIMEX 2 is a Class 2 device cleared via the FDA 510(k) pathway under K000454 with product code MUH and regulation number 872.1800. It was determined substantially equivalent and received clearance on March 31, 2000, following submission on February 11, 2000, by Planmeca Oy.

Similar devices

Other devices filed under FDA product code MUH (System, X-Ray, Extraoral Source, Digital).

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