Catalog Number

COSM300A

Brand Name

Ena Bond ®

Version/Model Number

COSM300A

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

K072978,K072978

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Public Device Record Key

4687a0b9-b8e9-4d39-9813-b8472599452d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 08, 2017

Package DI Number

EMICCOSM300A1

Quantity per Package

1

Contains DI Package

EMICCOSM300A0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PET-ALU-PE pouch