Catalog Number

M2D3M34I

Brand Name

ODIPAL

Version/Model Number

POSTERIOR TEETH D3/M34I

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070591

Product Code

ELM

Product Code Name

Denture, Plastic, Teeth

Public Device Record Key

57c2b31f-a850-4962-9838-ef5ab92c453e

Public Version Date

January 20, 2022

Public Version Number

1

DI Record Publish Date

January 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-