Catalog Number

-

Brand Name

3D Predict

Version/Model Number

3DS08

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

Yes

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

K200214

Product Code

NXC

Product Code Name

Aligner, Sequential

Public Device Record Key

13203be8-eb3d-43e7-8c9d-1d2bdc2f4dda

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

August 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-