Catalog Number

-

Brand Name

Hard Inlay Wax (ivory chunks)

Version/Model Number

5312-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 24, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EGD

Product Code Name

Wax, Dental, Intraoral

Public Device Record Key

925ae1b5-14b2-46f4-8f13-ca7661d57c74

Public Version Date

March 25, 2022

Public Version Number

2

DI Record Publish Date

November 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-