Catalog Number

54011

Brand Name

Splendid Posterior

Version/Model Number

54011

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)

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

0650b10d-6fbb-49ab-96e6-2c78bdd0eab1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 02, 2017

Package DI Number

17701126550119

Quantity per Package

20

Contains DI Package

07701126550112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box