Catalog Number

-

Brand Name

ET III SA Ultra-Wide Fixture No Mount

Version/Model Number

CET3R6010S

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140934

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

780d5d96-4373-48b9-8fb8-253912d8ec01

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-