Catalog Number

-

Brand Name

sureclear template

Version/Model Number

2000

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

960fb2b4-6b7d-4bbc-a8c5-7be8bd97523a

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

-