Catalog Number

-

Brand Name

SureCure

Version/Model Number

Aligners

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

K182329,K182329,K182329

Product Code

NXC

Product Code Name

Aligner, Sequential

Public Device Record Key

fc0b0d96-ad4d-404a-9fca-ae3d5142c53d

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 08, 2019

Package DI Number

D918SCA2

Quantity per Package

34

Contains DI Package

D918SCA1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box