Catalog Number

PS650

Brand Name

Plasdent

Version/Model Number

PS650

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

K201604,K201604,K201604

Product Code

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

42bad511-1550-4860-b3cb-8d8e7cdc9c62

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 25, 2022

Package DI Number

D832PS6502

Quantity per Package

10

Contains DI Package

D832PS6501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case