Catalog Number

AU-HV3115C

Brand Name

Evogue Dental Unit

Version/Model Number

Evogue Dental Unit

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

K152100

Product Code

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

846e7b78-fe6c-4cbc-8580-d811cb5ae3e3

Public Version Date

May 27, 2022

Public Version Number

2

DI Record Publish Date

November 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-