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Firecr Dentalimaging System

by 3Disc Americas

510(k) K131442

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 NumberK131442 Date6 Sep 2013ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The FireCR Dental Imaging System is a dental computed radiography reader and dental imaging system. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

The system is supplied as Rx Only and is intended for use in dental practices. It is a reusable device that requires appropriate cleaning and maintenance between uses. The device is classified as Class II under regulation number 872.1800 with product code MUH.

Other devices from 3Disc Americas

Questions

AI-generated answers, 1 Oct 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 FireCR Dental Imaging System used for?

    The FireCR Dental Imaging System is a dental computed radiography reader and imaging system intended for use in dental practices to capture and process digital radiographic images from reusable imaging plates.

  • Is the FireCR Dental Imaging System reusable or single-use?

    The FireCR Dental Imaging System is a reusable device that requires appropriate cleaning and maintenance between uses to ensure proper function and infection control in dental settings.

  • How is the FireCR Dental Imaging System supplied and who can use it?

    The system is supplied as Rx Only, meaning it is available by prescription only for use by licensed dental professionals in dental practices, not for over-the-counter or consumer use.