Catalog Number

-

Brand Name

Efferdent

Version/Model Number

10814832014626B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EFT

Product Code Name

Cleanser, Denture, Over The Counter

Public Device Record Key

332c1d0b-4b7a-45ca-85a6-bacdbb49b359

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

June 25, 2020

Package DI Number

10814832010130

Quantity per Package

1

Contains DI Package

00814832014629

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single