Catalog Number

-

Brand Name

YAMAHACHI PMMA DISK

Version/Model Number

95mm*14mm, D2

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

K151764

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

e65b647c-ff6e-4d5e-991b-706836babf1c

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

April 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-