Catalog Number

-

Brand Name

Vivid Surebond VII

Version/Model Number

D010450

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

9dcb4d44-42ae-4c99-afe4-187ddc82cf3a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-