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Intraoral Sensor

by Dentium Co., Ltd. (ICT Branch) South Korea 510(k)

510(k) K201247

Product code MQB

Overview

The Intraoral Sensor is a solid state x-ray imager (flat panel/digital imager) designed for intraoral use. It is a Class II medical device that captures digital dental images for diagnostic purposes.

The device is supplied in various models including IOX 1 and IOX 2, and is regulated under 21 CFR 892.1680 for stationary x-ray systems. It has received FDA 510(k) clearance with number K201247, indicating it is substantially equivalent to predicate devices.

Summary written by AI from registry data, 26 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201247 Date10 Jun 2020ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MQB
FDA applicant
Dentium Co., Ltd (Ict Branch)
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Intraoral Sensor used for?

    The Intraoral Sensor is a solid state x-ray imager designed for intraoral use. It captures digital dental images for diagnostic purposes, helping clinicians visualize dental structures and conditions accurately.

  • What models are available for the Intraoral Sensor?

    The Intraoral Sensor is supplied in various models including IOX 1 and IOX 2. These models may differ in specifications or features to accommodate different clinical needs and preferences.

  • Is the Intraoral Sensor a single-use or reusable device?

    The device is designed for multiple uses as it is a Class II medical device intended for capturing digital dental images. Proper cleaning and disinfection protocols should be followed between patients to ensure patient safety and device longevity.

  • What regulatory approvals does the Intraoral Sensor have?

    The Intraoral Sensor has received FDA 510(k) clearance with number K201247, indicating it is substantially equivalent to predicate devices. It is regulated under 21 CFR 892.1680 for stationary x-ray systems.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K201247 24 fields · synced 22 Oct 2026