Catalog Number

-

Brand Name

Trusana

Version/Model Number

TRU385-A1

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

300c9b6d-02aa-4b63-9418-a6322aa111ab

Public Version Date

October 18, 2021

Public Version Number

1

DI Record Publish Date

October 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-