Straumann RidgeFit Implants - Straumann® RidgeFit Implant, Ø 2.4mm, GH 2.8mm, - Institut Straumann AG

Duns Number:483599259

Device Description: Straumann® RidgeFit Implant, Ø 2.4mm, GH 2.8mm, SLA®, 14mm, TiN, Roxolid®

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More Product Details

Catalog Number

042.949S

Brand Name

Straumann RidgeFit Implants

Version/Model Number

Mini Implants

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

-

Product Code Details

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Device Record Status

Public Device Record Key

da98d62b-9607-4c28-b338-cfc589933bb9

Public Version Date

March 30, 2022

Public Version Number

2

DI Record Publish Date

August 03, 2021

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