Catalog Number

-

Brand Name

Britedent

Version/Model Number

BSI-2000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KXR

Product Code Name

Applicator, Resin

Public Device Record Key

3be0f752-f26f-4c5e-b370-75da7b8d1edf

Public Version Date

August 19, 2022

Public Version Number

1

DI Record Publish Date

August 11, 2022

Package DI Number

D974BSI20002

Quantity per Package

4

Contains DI Package

D974BSI20001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tubes