Catalog Number

60019541

Brand Name

ONE COAT 7 UNIVERSAL

Version/Model Number

60019541

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

K152243

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

800ecf9a-67e9-4a79-a21f-b51f46675c03

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-