Catalog Number

559584AN

Brand Name

Systemp.inlay Systemp.onlay

Version/Model Number

559584AN

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 23, 2020

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

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Public Device Record Key

dfbe2e7c-c9f6-48b1-afd2-719af9433635

Public Version Date

April 23, 2020

Public Version Number

3

DI Record Publish Date

December 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-