Intra Oral Sensor

FDA UDI

Class II (US FDA UDI)

by Dentium Co., Ltd.

Identity

Trade Name: Intra Oral Sensor FDA UDI
Generic Name: Dental digital imaging sensor, intraoral FDA UDI
Device Name: Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays. FDA UDI
Model / Reference: IOX2 FDA UDI
Description: Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays. FDA UDI

Identifiers

Catalog Number: IOX2 FDA UDI
Primary DI / UDI-DI: 08809460309867 FDA UDI
510(k) Number: K201247 FDA UDI
FDA Product Code: MQB FDA UDI
MUH FDA UDI
GMDN Term: Dental digital imaging sensor, intraoral FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 FDA UDI
872.1800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental digital imaging sensor, intraoral

Intra Oral Sensor by Dentium Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental digital imaging sensor, intraoral.

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XIOS XG SUPREME — SIRONA DENTAL, INC. · Class II
SCHICK33 — SIRONA DENTAL, INC. · Class II
XIOS XG WIFI — SIRONA DENTAL, INC. · Class II

Cleared under the same submission

K201247 also covers:

Intra Oral Sensor — Dentium Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dentium Co., Ltd.

Sources (1)

FDA UDI 6473846e-18eb-417e-96db-17c2b318671f 37 fields · synced May 31, 2026