Implantium, Superline - Endosseous Dental Implant Abutment - Dentium Co., Ltd.

Duns Number:689514395

Device Description: Endosseous Dental Implant Abutment

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More Product Details

Catalog Number

DAB6515N

Brand Name

Implantium, Superline

Version/Model Number

DAB6515N

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

K172640

Product Code Details

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Record Status

Public Device Record Key

7270581d-76b6-4f06-a3b8-7ad8f00e7394

Public Version Date

November 30, 2020

Public Version Number

1

DI Record Publish Date

November 21, 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 835
2 A medical device with a moderate to high risk that requires special controls. 1469