Catalog Number

-

Brand Name

Aidite Pmma

Version/Model Number

Multilayer

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

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

K190217

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

2a9cff43-b753-4481-9d6f-4395d38931cc

Public Version Date

April 18, 2022

Public Version Number

1

DI Record Publish Date

April 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-