Catalog Number

TIPS

Brand Name

Ribbond Securing Composite

Version/Model Number

1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

4b1417f9-71a7-48a4-a897-92022f64ad79

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 31, 2017

Package DI Number

D046C1

Quantity per Package

4

Contains DI Package

D046CC0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-