Catalog Number

SM-100-LC

Brand Name

SmartBond LC

Version/Model Number

SM-100-LC

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

K981036

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Public Device Record Key

6bd0d2a9-9179-4b60-a31f-d891ee1fa993

Public Version Date

October 23, 2020

Public Version Number

1

DI Record Publish Date

October 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-