BONASIL A+ Putty - Addition curing vinyl polysiloxane impression - DMP DENTAL INDUSTRY S.A.

Duns Number:728534814

Device Description: Addition curing vinyl polysiloxane impression material

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More Product Details

Catalog Number

-

Brand Name

BONASIL A+ Putty

Version/Model Number

380ml

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

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

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

c3e894b8-d2fc-4e74-a9ba-4a9ef0883849

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

05206569560039

Quantity per Package

2

Contains DI Package

05206569560022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"DMP DENTAL INDUSTRY S.A." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 101