Catalog Number

908127

Brand Name

Radica®

Version/Model Number

Dentin D4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 05, 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

24a2e0ff-1cbc-4ee2-b2c1-a8299c9c02c2

Public Version Date

May 06, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-