Straumann TLX Implant System - TLX S Implant, Ø 3.75mm RT, SLA® 8mm, Roxolid® - Institut Straumann AG

Duns Number:483599259

Device Description: TLX S Implant, Ø 3.75mm RT, SLA® 8mm, Roxolid®

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

035.0108S

Brand Name

Straumann TLX Implant System

Version/Model Number

SLA Roxolid TL

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

K200586

Product Code Details

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Record Status

Public Device Record Key

9b66f028-c9e0-4bd8-b342-09fa0abef59c

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTITUT STRAUMANN AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 52
2 A medical device with a moderate to high risk that requires special controls. 2726
3 A medical device with high risk that requires premarket approval 5