TiBase - TiBase AT EV 5.4 GH1 L - SIRONA Dental Systems GmbH

Duns Number:340306351

Device Description: TiBase AT EV 5.4 GH1 L

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More Product Details

Catalog Number

6586346

Brand Name

TiBase

Version/Model Number

6586346

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

6a1a6ac1-d5d6-4075-a930-511870f3cace

Public Version Date

May 17, 2022

Public Version Number

2

DI Record Publish Date

January 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIRONA DENTAL SYSTEMS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 235
2 A medical device with a moderate to high risk that requires special controls. 326