Catalog Number

5500520

Brand Name

AeroPro Cordless Prophy System

Version/Model Number

AP-18-PDPC

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"

-

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

K180682

Product Code

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Public Device Record Key

515ec70d-b826-46d3-add4-77818b9df2f3

Public Version Date

March 18, 2020

Public Version Number

1

DI Record Publish Date

March 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-