Catalog Number

640406

Brand Name

SR Nexco

Version/Model Number

640406

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

4e237252-3e10-4df2-b685-a662a4a3352b

Public Version Date

October 11, 2022

Public Version Number

2

DI Record Publish Date

August 22, 2022

Package DI Number

07615208433098

Quantity per Package

10

Contains DI Package

07615208006216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-