Catalog Number

-

Brand Name

Infinix Bulk Fill Flow Composite

Version/Model Number

INF-BF-PP-MD-A1

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

K201010,K201010

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

eaa693dd-5591-4511-8896-d6bf5c2e67b8

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 15, 2021

Package DI Number

17290017528134

Quantity per Package

1

Contains DI Package

07290017528106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-