Catalog Number

51101

Brand Name

Adper™

Version/Model Number

51101

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

-

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

6239f03c-3b24-4baa-8be3-c145ad971112

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

50605861014156

Quantity per Package

10

Contains DI Package

30605861014152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX