Catalog Number

13780US

Brand Name

Visalys Temp A1 USA Normal pack

Version/Model Number

13780US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 11, 2017

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

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

K122039

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

54fab8d3-f2d1-43f6-9586-c662e295dca3

Public Version Date

October 29, 2021

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-