Catalog Number

XS-REGAM-2

Brand Name

Plasdent

Version/Model Number

XS-REGAM-2

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

31ff8d46-2319-49ac-8ec9-1c0a15629176

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 26, 2022

Package DI Number

D832XSREGAM22

Quantity per Package

20

Contains DI Package

D832XSREGAM21

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case