Catalog Number

50-122

Brand Name

SciPharm CuRay Fil Light Cure Composite Resin

Version/Model Number

SP 50-122 B

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

K850675

Product Code

EBD

Product Code Name

Coating, Filling Material, Resin

Public Device Record Key

1afe0d30-9088-4d92-85c7-fffec2af3cd0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-