Catalog Number

001497

Brand Name

GRADIA®

Version/Model Number

001497

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

-

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

K001518

Product Code

EBF

Product Code Name

Material, tooth shade, resin

Public Device Record Key

e0bb4237-a776-4cc1-8dc1-2571454b9dcd

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-