BioHPP for2press - 150 g - BioHPP for2press - 150 g 10 pellets ds2 of 15 g - bredent GmbH & Co. KG

Duns Number:341086190

Device Description: BioHPP for2press - 150 g 10 pellets ds2 of 15 g each dentin-shade 2 10 Pieces

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

540F2P25

Brand Name

BioHPP for2press - 150 g

Version/Model Number

540F2P25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

dd4b5ee8-7455-453e-a802-9e31d1d8e514

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

EBRE540F2P259

Quantity per Package

1

Contains DI Package

EBRE540F2P250

Package Discontinue Date

September 20, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy

"BREDENT GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 375