Catalog Number

01060020

Brand Name

Pekkton ivory

Version/Model Number

01060020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170102

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

66820f17-ed1c-4039-9bdd-392f0f283217

Public Version Date

March 27, 2020

Public Version Number

3

DI Record Publish Date

July 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-