Catalog Number

N1030

Brand Name

Power Dental U.S.A., Inc.

Version/Model Number

N1030

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

EKB

Product Code Name

EXPLORER, OPERATIVE

Public Device Record Key

4bc92a19-178c-46cb-a2ee-65ec505469d4

Public Version Date

June 28, 2021

Public Version Number

1

DI Record Publish Date

June 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-