Catalog Number

002-959MLL

Brand Name

Silkon Plus

Version/Model Number

002-959MLL

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

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

K891372

Product Code

DYW

Product Code Name

BRACKET, PLASTIC, ORTHODONTIC

Public Device Record Key

cbaad777-9541-4b16-a5c4-6c8b83632316

Public Version Date

August 16, 2021

Public Version Number

1

DI Record Publish Date

August 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-