Catalog Number

-

Brand Name

CROWN PX-A/EFUCERA PX-P COMBINATION SET

Version/Model Number

S51SN4228, C1

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)

Yes

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

5546c36f-ee38-4fda-9e14-1601633c48d8

Public Version Date

November 29, 2021

Public Version Number

1

DI Record Publish Date

November 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-