Catalog Number

R312

Brand Name

PDT, Inc.

Version/Model Number

R312 D11 Endo Spreader

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

-

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

EKK

Product Code Name

Spreader, Pulp Canal Filling Material, Endodontic

Public Device Record Key

6e09f7f0-9b0b-4ed8-94d3-d537c9acae14

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-