Catalog Number

-

Brand Name

Contra Angle 32:1

Version/Model Number

5054NOU

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

K022505

Product Code

EGS

Product Code Name

Handpiece, Contra- And Right-Angle Attachment, Dental

Public Device Record Key

cdc700c4-fe00-4eae-a360-c80001c044ee

Public Version Date

September 21, 2018

Public Version Number

1

DI Record Publish Date

August 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-