Catalog Number

752001

Brand Name

Denticator

Version/Model Number

752001

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K974671,K974671

Product Code

EFB

Product Code Name

Handpiece, air-powered, dental

Public Device Record Key

b03596b7-4b40-4558-abdd-c27cbc141dc2

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

10302737520019

Quantity per Package

1

Contains DI Package

00302737520012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box