Catalog Number

90661

Brand Name

RE-GEN Bulk Fill Composite and Resin Cement Kit A4

Version/Model Number

1

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

K091647

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

ec9d451f-bda1-4c83-8fbe-b1a6534f3392

Public Version Date

February 04, 2021

Public Version Number

5

DI Record Publish Date

June 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-