Catalog Number

1C500-BL

Brand Name

ESSIX C+®

Version/Model Number

1C500-BL

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"

Yes

For Single-Use

Yes

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

K062828,K062828

Product Code

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Public Device Record Key

bc51b618-cb1f-48cf-82b0-9efa6950e712

Public Version Date

October 15, 2020

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-