Catalog Number

-

Brand Name

OCS ETCH GEL SYRINGE

Version/Model Number

008-031

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 29, 2017

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

-

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Public Device Record Key

0a208b37-9d73-405c-8d19-d60d497ea9ca

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

January 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-