Catalog Number

S321

Brand Name

HyperFIL™

Version/Model Number

S321

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2021

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

-

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

09aa159e-e5f9-439f-af15-b2dd9d55caa6

Public Version Date

June 08, 2021

Public Version Number

3

DI Record Publish Date

October 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-