Catalog Number

635337AN

Brand Name

Telio CS Inlay Telio CS Onlay

Version/Model Number

635337AN

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 20, 2022

Issuing Agency

In HIBCC

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

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

90f10e50-4b43-49cb-a75a-88df652497b7

Public Version Date

July 21, 2022

Public Version Number

4

DI Record Publish Date

December 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-