Catalog Number

-

Brand Name

Infinix Universal Bond- Bond

Version/Model Number

INF-BOND-PP-MD2.5ML

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

Yes

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

K183391,K183391

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

69e16bac-ac10-4929-a77c-4464c330ae39

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Package DI Number

17290017528400

Quantity per Package

1

Contains DI Package

07290017528298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-