Catalog Number

5119E

Brand Name

Power Dental USA

Version/Model Number

5119E

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EIY

Product Code Name

INSTRUMENT, FILLING, PLASTIC, DENTAL

Public Device Record Key

5dcb0bd5-0c24-459e-b430-ee0a277faa43

Public Version Date

March 24, 2022

Public Version Number

2

DI Record Publish Date

January 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-