Catalog Number

Q40004

Brand Name

Quala

Version/Model Number

Q40004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2017

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

K941899,K941899

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

ab808c88-2e17-4f47-b7b2-10a7929a63bb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

D023Q400043

Quantity per Package

24

Contains DI Package

D023Q4000418

Package Discontinue Date

April 25, 2017

Package Status

Not in Commercial Distribution

Package Type

Case