Catalog Number

754798WW

Brand Name

Adhese Universal

Version/Model Number

754798WW

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 15, 2022

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

-

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

-

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

f47c31b1-6261-4911-ae9b-e27421c31ac8

Public Version Date

March 16, 2022

Public Version Number

2

DI Record Publish Date

October 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-