Catalog Number

-

Brand Name

Primado2

Version/Model Number

P200-EZ-SM

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

K163483

Product Code

EFB

Product Code Name

Handpiece, air-powered, dental

Public Device Record Key

a5e6bc14-e421-47f2-9941-652477cdc50d

Public Version Date

June 15, 2020

Public Version Number

1

DI Record Publish Date

June 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-