Catalog Number

B-4101

Brand Name

Universal Primer

Version/Model Number

B-4101

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

K131734

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

fa649bbc-f182-4f9c-9f0a-09efec146a8d

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-