Catalog Number

670450

Brand Name

Denticator

Version/Model Number

670450

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

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

K151123,K151123,K151123

Product Code

PEM

Product Code Name

Dental barriers and sleeves

Public Device Record Key

fdd217d9-fa7c-4636-8231-a52080b3e126

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

10302730002390

Quantity per Package

500

Contains DI Package

00302730002393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box