Catalog Number

020-028537

Brand Name

Acid Etchant Gel Syringe Tip

Version/Model Number

020-028537

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2021

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

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

K872569

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

3d99ab7d-a9fc-4f47-8ad2-47b904b60cd7

Public Version Date

June 04, 2021

Public Version Number

4

DI Record Publish Date

May 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-