Catalog Number

54TF2PB2

Brand Name

BioHPP TU for2press 20g

Version/Model Number

54TF2PB2

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Public Device Record Key

92f9fa06-ec69-4164-bf57-60f637da70b7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Package DI Number

EBRE54TF2PB29

Quantity per Package

1

Contains DI Package

EBRE54TF2PB20

Package Discontinue Date

September 20, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy