Catalog Number

E-5674

Brand Name

Etch-37 w/BAC

Version/Model Number

E-5674

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

-

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

2adbb10f-0e17-4aef-b7eb-0ac0d8c68df9

Public Version Date

October 11, 2022

Public Version Number

2

DI Record Publish Date

September 19, 2022

Package DI Number

10810111541074

Quantity per Package

1

Contains DI Package

00810111541077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Item No: E-56741P