Catalog Number

9012006

Brand Name

e-1 Seafoam 37% Phosphoric acid gel etchant

Version/Model Number

9012006

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

-

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Public Device Record Key

ecb3cd80-5344-4dc0-8a80-0db669a7ecb3

Public Version Date

February 10, 2020

Public Version Number

1

DI Record Publish Date

January 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-