Catalog Number

-

Brand Name

Refine Bright

Version/Model Number

10kg, LFα

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

K131036

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Public Device Record Key

0c3c9013-b35e-4be8-9c9a-8b3c4e7186a4

Public Version Date

July 17, 2019

Public Version Number

1

DI Record Publish Date

July 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-