Catalog Number

CAL-LINER

Brand Name

Select Calcium Hydroxide Liner LC

Version/Model Number

CAL-LINER

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

EJK

Product Code Name

Liner, Cavity, Calcium Hydroxide

Public Device Record Key

97e09edf-86f0-4e96-9de8-26634bbadb46

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 26, 2017

Package DI Number

17540208000384

Quantity per Package

1

Contains DI Package

07540208000387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton