Catalog Number

001-913

Brand Name

Acid Etching

Version/Model Number

001-913

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2019

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

4bf9fb89-b1c4-4cdc-8ec4-63a1e8d35757

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

November 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-