Implantium, Superline - Endosseous dental implant - Dentium Co., Ltd.

Duns Number:689514395

Device Description: Endosseous dental implant

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More Product Details

Catalog Number

FXS6010C

Brand Name

Implantium, Superline

Version/Model Number

FXS6010C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160965

Product Code Details

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Record Status

Public Device Record Key

90b8be82-de6b-4c9b-afe8-750859a6284e

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 20, 2021

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 835
2 A medical device with a moderate to high risk that requires special controls. 1469