Catalog Number

N5805RH

Brand Name

Power Dental U.S.A., Inc.

Version/Model Number

N5805RH

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

ECS

Product Code Name

PUSHER, BAND, ORTHODONTIC

Public Device Record Key

36a62fe2-472a-4052-9687-0dd7568f000d

Public Version Date

July 21, 2021

Public Version Number

1

DI Record Publish Date

July 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-