Catalog Number

-

Brand Name

MicroP Dental

Version/Model Number

A004

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

K173943

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

e885865f-053a-4d93-acc1-588dfef4c052

Public Version Date

December 22, 2020

Public Version Number

2

DI Record Publish Date

August 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-