Catalog Number

908109

Brand Name

Radica®

Version/Model Number

Dentin i2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 13, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBD

Product Code Name

COATING, FILLING MATERIAL, RESIN

Public Device Record Key

5c030a0b-8a8c-41f9-8b89-6551786dfbf5

Public Version Date

May 16, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

D0019083451

Quantity per Package

12

Contains DI Package

D0019081090

Package Discontinue Date

May 12, 2022

Package Status

Not in Commercial Distribution

Package Type

-