Catalog Number

J815

Brand Name

ORAPRO

Version/Model Number

J815

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

K935625

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Public Device Record Key

0e33a447-110e-4ab0-986c-2273359c37fc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-