Catalog Number

-

Brand Name

VITAPAN Plus

Version/Model Number

AVD3O47L

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

K914476

Product Code

ELM

Product Code Name

Denture, plastic, teeth

Public Device Record Key

126bcfa1-9268-4713-9c46-673ca88e1cba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-