Catalog Number

-

Brand Name

sureclear aligner

Version/Model Number

1000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2019

Issuing Agency

In GS1

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

K171860

Product Code

NXC

Product Code Name

Aligner, Sequential

Public Device Record Key

3af726e4-730a-4c22-bb7e-d773e9fffb08

Public Version Date

May 17, 2022

Public Version Number

5

DI Record Publish Date

March 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-