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RX DC X-Ray Unit

by Cefla S.C.R.L.

510(k) K080076

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K080076↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK080076 Date14 Mar 2008ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Overview

AI-generated summary, 18 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 RX DC X-Ray Unit is an extraoral dental X-ray device designed for capturing radiographic images of teeth and surrounding structures. It operates with a timer function to control exposure duration, ensuring precise imaging for diagnostic purposes in dental practice.

This device is supplied as a reusable medical instrument, intended for use in dental clinics and offices. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The unit requires proper installation, electrical setup, and maintenance as outlined in its technical manual, with no specific sterility requirements stated for reusable components.

Other devices from Cefla S.C.R.L.

  • C-U2

    Class I

  • Wds, Size 2 and Size 2

    Class II

Questions

AI-generated answers, 18 Sep 2026

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

  • Is the RX DC X-Ray Unit designed for single-use or can it be reused in a dental practice?

    The RX DC X-Ray Unit is explicitly described as a reusable medical instrument. Since it is classified as a reusable device, it does not require sterility for its components and is intended for repeated use in dental clinics and offices, provided proper installation, electrical setup, and maintenance are followed as outlined in its technical manual.

  • What types of dental images can this X-ray unit capture, and how does the timer function assist in imaging?

    The RX DC X-Ray Unit is designed specifically for extraoral dental imaging, meaning it captures radiographic images of teeth and surrounding structures from outside the mouth. The built-in timer function allows precise control over exposure duration, ensuring clear and accurate diagnostic images without overexposure or underexposure.

  • Does this device require any special handling or storage conditions beyond standard electrical and mechanical maintenance?

    While the RX DC X-Ray Unit does not have explicit sterility requirements for its reusable components, it does require proper installation, electrical setup, and maintenance as detailed in its technical manual. Storage should follow general guidelines for medical imaging equipment—protected from physical damage, extreme temperatures, and moisture—to ensure optimal performance and longevity.

  • What regulatory pathways has this device undergone, and how does that affect its use in dental practices?

    The RX DC X-Ray Unit has received FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for safety and effectiveness as a Class II medical device. This means it is legally permitted for use in dental practices in the U.S. and EU markets, provided it is installed, operated, and maintained according to manufacturer guidelines and applicable regulations.