Catalog Number

54000830

Brand Name

Silano-Pen Gas cartridge

Version/Model Number

54000830

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBI

Product Code Name

RESIN, DENTURE, RELINING, REPAIRING, REBASING

Public Device Record Key

e21feb5e-bb0b-4907-be55-e6ff342824f6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

EBRE540008309

Quantity per Package

1

Contains DI Package

EBRE540008300

Package Discontinue Date

September 22, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy