Catalog Number

-

Brand Name

CEREC Ortho Software

Version/Model Number

6611169

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2021

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

PNN

Product Code Name

Orthodontic Software

Public Device Record Key

34469ffc-aeef-4b44-96dd-53892ea55e41

Public Version Date

May 17, 2022

Public Version Number

4

DI Record Publish Date

September 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-