Catalog Number

RB120CASE

Brand Name

RETAINER BRITE®

Version/Model Number

RB120CASE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EFT

Product Code Name

CLEANSER, DENTURE, OVER THE COUNTER

Public Device Record Key

292b1b82-ddae-4ca8-a887-6f19af0d775a

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

May 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-