Catalog Number

-

Brand Name

ORTHOSOURCE

Version/Model Number

557-475

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K861258,K861258

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Public Device Record Key

ee3b74c4-2d17-45c8-9355-73e3bf67cc9c

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

Package DI Number

D9115574770

Quantity per Package

6

Contains DI Package

D9115574750

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

6 x 6 gm Syringe Kit