Catalog Number

013646

Brand Name

G2-Bond Universal

Version/Model Number

013646

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

-

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

K200682

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

4c046b64-a363-4a5c-91fc-90c9dbd6313a

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-