Catalog Number

010636

Brand Name

Dentalor 60

Version/Model Number

010636_1OZ

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 24, 2020

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

EJT

Product Code Name

Alloy, Gold-Based Noble Metal

Public Device Record Key

4340588c-c887-444b-9f7c-be8c73179e63

Public Version Date

May 04, 2021

Public Version Number

3

DI Record Publish Date

April 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-