R-SI-LINE ® MONO S SCAN - R-SI-LINE ® MONO S SCAN is an universal, really - R-Dental Dentalerzeugnisse GmbH

Duns Number:313956880

Device Description: R-SI-LINE ® MONO S SCAN is an universal, really direct scannable one-phase precision impre R-SI-LINE ® MONO S SCAN is an universal, really direct scannable one-phase precision impression material based on vinyl polysiloxane (VPS) recommended for the CAD/CAM/CIM-technology. The white-lilac A-silicone is indicated for functional impressions and one-phase impressions like impressions for crowns, bridges, inlays, partial and complete dentures and denture repairs and impressions for prosthetic restorations. R-SI-LINE ® MONO S SCAN guarantees a precise detail reproduction due to its superhydophilic consistency, which ensures an excellent wetting of the tooth structure. It provides an excellent scannability and a very good Snap-Set. The product is available in standard 50 ml auto-mixing cartridges plus 12 mixing cannulas. It can be dispensed with a commercial dispenser.

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More Product Details

Catalog Number

MOK0475

Brand Name

R-SI-LINE ® MONO S SCAN

Version/Model Number

MOK0475

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)

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

8086641c-3bed-496e-a7f2-5bcb1ba613de

Public Version Date

April 10, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"R-DENTAL DENTALERZEUGNISSE GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1