Catalog Number

-

Brand Name

ZA-55 Synea Scaler

Version/Model Number

10035531

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

-

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

d2161102-b562-44cd-b86e-2e6ad276b088

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-