Identifiers
- 510(k) Number
- K000454 FDA 510(k)
- FDA Product Code
- MUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1800 FDA 510(k)
- Regulation Number
- 872.1800 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is the DIMEX 2 used for?
The DIMEX 2 is an extraoral source x-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures, with the x-ray source located outside the mouth.
How is the DIMEX 2 powered and what type of device is it?
The DIMEX 2 is an AC-powered device that produces x-rays and is classified as an extraoral source x-ray system for dental imaging.
What regulatory pathway was used for the DIMEX 2 and when was it cleared?
The DIMEX 2 was cleared via the FDA 510(k) pathway under submission K000454, determined substantially equivalent, and received clearance on March 31, 2000.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DIMEX 2 (K000454) — FDA 510 (k) | Innolitics, Dimex 2 - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K000454 | Class II | Active |
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Manufacturer
- Manufacturer
- Planmeca Oy
Sources (1)
- FDA 510(k) K000454 24 fields · synced Sep 25, 2026