Catalog Number

-

Brand Name

LUXEN Smile, LUXEN Zr

Version/Model Number

ML 1200 600 Multi P D98 MHT Medium 12T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

K171585

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

91261912-3732-4cf6-950e-407ffa40d34e

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-