Catalog Number

12606131

Brand Name

GlamaFlow Flowable Composite

Version/Model Number

12606131

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120768,K120768

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

86475b94-a2bd-45ca-9505-5277958434e4

Public Version Date

December 21, 2018

Public Version Number

1

DI Record Publish Date

November 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-