Catalog Number

H-931C2

Brand Name

3g Bulk Fill Composite C2 Syringe

Version/Model Number

H-931C2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 12, 2017

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

-

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

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

30c8c3d7-0c41-47b2-a696-0124d59b3650

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-