Catalog Number

51-302

Brand Name

SciPharm NewCore, Core Build-Up Restorative Automix

Version/Model Number

SP 51-302 C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

K810479

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

bde37fe6-761d-4f22-b978-c7a342daf8e5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-