Catalog Number

1700390-001

Brand Name

Set Optima MX2 INT PRO + TR

Version/Model Number

1700390-001

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

EIA

Product Code Name

Unit, operative dental

Public Device Record Key

3063f322-3add-4eba-80e1-46b6991bae81

Public Version Date

June 25, 2021

Public Version Number

1

DI Record Publish Date

June 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-