Catalog Number

-

Brand Name

Yamahachi Pink CAD/CAM Disk (JUSTI)

Version/Model Number

30mm, LIGHT

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

K172683

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Public Device Record Key

5f98514c-f521-4b17-a79e-753f1a3a9398

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

August 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-