Catalog Number

PS850

Brand Name

Plasdent

Version/Model Number

PS850

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

NRD

Product Code Name

Unit, Operative Dental, Accessories

Public Device Record Key

17b6adde-fc18-49fa-99fa-ff7103c7c563

Public Version Date

September 07, 2022

Public Version Number

1

DI Record Publish Date

August 30, 2022

Package DI Number

D832PS8502

Quantity per Package

8

Contains DI Package

D832PS8501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case