Catalog Number

0011538

Brand Name

Ultradent Posterior

Version/Model Number

0011538

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

9a588cea-7f96-43d4-8e00-4afd1ca7bf60

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 24, 2017

Package DI Number

17701126550133

Quantity per Package

20

Contains DI Package

07701126550136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX