Catalog Number

0120083

Brand Name

EVO 2 ST

Version/Model Number

EVO 2 ST 8 LOWER

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

PZY

Product Code Name

Additively Manufactured, Preformed, Resin Denture Tooth

Public Device Record Key

8f925615-4c52-4846-91b8-2e058019f84f

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

February 27, 2020

Package DI Number

28056865012838

Quantity per Package

12

Contains DI Package

08056865012834

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-