Catalog Number

001-970M

Brand Name

Bandtite Band Cement

Version/Model Number

001-970M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 29, 2018

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

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

91d77464-037a-4b7e-a978-2acedc097a6c

Public Version Date

June 22, 2020

Public Version Number

4

DI Record Publish Date

December 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-