Catalog Number

PRV.32IB3

Brand Name

PRIMODENT

Version/Model Number

PRV.32IB3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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

-

Product Code

ELM

Product Code Name

Denture, plastic, teeth

Public Device Record Key

0845ad05-f8b6-4d10-8670-38dc9cf7887b

Public Version Date

June 23, 2021

Public Version Number

1

DI Record Publish Date

June 15, 2021

Package DI Number

EPOLPRV32IB303

Quantity per Package

1

Contains DI Package

EPOLPRV32IB3

Package Discontinue Date

June 15, 2021

Package Status

Not in Commercial Distribution

Package Type

plastic card