KONTACT S - Implant Øexternal 4.0mm L08mm Øcore 3.6mm - BIOTECH DENTAL

Duns Number:265382983

Device Description: Implant Øexternal 4.0mm L08mm Øcore 3.6mm

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More Product Details

Catalog Number

-

Brand Name

KONTACT S

Version/Model Number

K4008-36S

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

K213997

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

98c4d31e-78eb-499a-a2bf-dcfb28bc7c4a

Public Version Date

August 04, 2022

Public Version Number

1

DI Record Publish Date

July 27, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOTECH DENTAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72
2 A medical device with a moderate to high risk that requires special controls. 485