Catalog Number

006-00044

Brand Name

BlissBond Intro Kit

Version/Model Number

006-00044

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092616,K092616

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

8e3a3c66-07cd-40f4-a51a-a0f69ef5de2d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-