Intra Oral Sensor - Intra Oral Sensor (model: IOX 1 / IOX 2) is a - Dentium Co., Ltd

Duns Number:695504638

Device Description: Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.

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More Product Details

Catalog Number

IOX1

Brand Name

Intra Oral Sensor

Version/Model Number

IOX1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K201247

Product Code Details

Product Code

MQB

Product Code Name

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device Record Status

Public Device Record Key

e3f25441-8298-4d9d-b5a3-0c05ed4f86c9

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTIUM CO., LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 5