Catalog Number

-

Brand Name

N.A.

Version/Model Number

AGA121LO

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 22, 2020

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

cffd725a-5c3b-4f2a-8b01-ec80f3a34b67

Public Version Date

June 01, 2020

Public Version Number

1

DI Record Publish Date

May 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-