Base metal alloy - ticon Titanium 5 units bridge framework - Institut Straumann AG

Duns Number:483599259

Device Description: ticon Titanium 5 units bridge framework

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More Product Details

Catalog Number

010.2005

Brand Name

Base metal alloy

Version/Model Number

Bridges (tooth borne)

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

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

-

Product Code Details

Product Code

EJH

Product Code Name

ALLOY, METAL, BASE

Device Record Status

Public Device Record Key

95e296f5-b3d3-452d-80be-d1672009eb01

Public Version Date

September 09, 2019

Public Version Number

1

DI Record Publish Date

August 31, 2019

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