Catalog Number

COSZ10-2

Brand Name

Ena Seal ®

Version/Model Number

COSZ10-2

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

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Public Device Record Key

fba51198-69f6-4e1f-a231-6348ae5f0ee0

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-