Catalog Number

FIL-RS-A3

Brand Name

Select NanoFill

Version/Model Number

FIL-RS-A3

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

85d4f3e9-6555-4026-bb89-d3ae646ce6b9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 21, 2017

Package DI Number

17540208000070

Quantity per Package

1

Contains DI Package

07540208000073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton