Catalog Number

290-HT9007

Brand Name

Health-Tec VPS Impression Material

Version/Model Number

290-HT9007

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 28, 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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K801380,K801380,K801380

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

68e478b6-a08f-4d71-8c2e-6f1b455b3b20

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

D773290HT90073I

Quantity per Package

10

Contains DI Package

D773290HT90071

Package Discontinue Date

April 28, 2017

Package Status

Not in Commercial Distribution

Package Type

-