EX-3 PRESS LF - Internal Stain Fluoro 3g - KURARAY NORITAKE DENTAL INC.

Duns Number:697119498

Device Description: Internal Stain Fluoro 3g

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

EX-3 PRESS LF

Version/Model Number

108-1981KA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K052304

Product Code Details

Product Code

EIH

Product Code Name

Powder, Porcelain

Device Record Status

Public Device Record Key

1318bb39-a4dc-454e-931c-7f09cbb082c4

Public Version Date

August 10, 2021

Public Version Number

5

DI Record Publish Date

February 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KURARAY NORITAKE DENTAL INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3252