Catalog Number

0099405FG

Brand Name

Aladdin™ Total Self-Cure Activator

Version/Model Number

0099405FG

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

-

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

K964525,K964525

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

f3aab69e-f901-4828-a50b-cea15c3f6aec

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

D6870099405FG2

Quantity per Package

15

Contains DI Package

D6870099405FG1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box