Catalog Number

-

Brand Name

POLYALL CURING LIGHT SLEEVE

Version/Model Number

6070553319

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

K163447,K163447

Product Code

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

df1f5284-4ca0-4fa5-933d-6241cdb9ff8e

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-