Catalog Number

861-205

Brand Name

Orthodontic Silicone Wax

Version/Model Number

861-205

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 18, 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

EGD

Product Code Name

WAX, DENTAL, INTRAORAL

Public Device Record Key

2617c48b-0f2d-4b2b-a990-f8a53013ded8

Public Version Date

July 23, 2020

Public Version Number

2

DI Record Publish Date

June 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-