Catalog Number

21315-121

Brand Name

NovaPro Fill

Version/Model Number

21315-121

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

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Public Device Record Key

38e3b613-99f3-492a-9941-0bfe5460c33c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

10816537020254

Quantity per Package

2

Contains DI Package

00816537020257

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-