Catalog Number

BW000

Brand Name

Cavex Bite&White patient kit

Version/Model Number

BW000

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

-

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

EEG

Product Code Name

Heat Source For Bleaching Teeth

Public Device Record Key

9970db5e-4595-4d36-a48c-e120aab6430e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-