Catalog Number

-

Brand Name

Vivid TruEtch 40% Jumbo syringe

Version/Model Number

H65-0308

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

b1c4719b-20c5-4b65-9c6f-1a122f5d720c

Public Version Date

June 11, 2018

Public Version Number

1

DI Record Publish Date

May 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-