Catalog Number

H-854CL

Brand Name

Aelite Aesthetic Enamel

Version/Model Number

H-854CL

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

-

Product Code

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Public Device Record Key

7296ef0c-f495-4640-9839-ff236b3098bc

Public Version Date

October 21, 2022

Public Version Number

1

DI Record Publish Date

October 13, 2022

Package DI Number

20810111541675

Quantity per Package

1

Contains DI Package

10810111541678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Item No: H-854CLP