Catalog Number

102-05001

Brand Name

I-Sil Dynamic Heavy Body

Version/Model Number

102-5001

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

K110428,K110428,K110428

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

58fca777-89cb-4af7-a33d-8356bb6f5c79

Public Version Date

March 13, 2019

Public Version Number

2

DI Record Publish Date

August 21, 2018

Package DI Number

20200831618083

Quantity per Package

100

Contains DI Package

08809262959963

Package Discontinue Date

March 12, 2019

Package Status

Not in Commercial Distribution

Package Type

-