R-SI-LINE ® MONO S SCAN
- Primary DI
- ERDEMOK04751
- Brand
- R-SI-LINE ® MONO S SCAN
- Company
- R-Dental Dentalerzeugnisse GmbH
- Model
- MOK0475
- Catalog number
- MOK0475
- Device description
- 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.
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| ELW | Material, Impression |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ELW | Material, Impression | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| ERDEMOK04751 | Primary | HIBCC | 0 | |
| CARTRIDGES2 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 4 Degrees Celsius | 25 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +4940307070730 | info@r-dental.com |
Regulatory Flags
- DUNS number
- 313956880
- Device count
- 2
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| ERDEKMK10881 | KwikkModel ® SCAN | KMK1088 | KMK1088 | 2016-09-24 |
| ERDEMBK04751 | R-SI-LINE ® METAL-BITE ® Blue | MBK0475 | MBK0475 | 2016-09-24 |
| ERDEMBK07501 | R-SI-LINE ® METAL-BITE ® GOLD | MBK0750 | MBK0750 | 2016-09-24 |
| ERDEMBK10741 | R-SI-LINE ® METAL-BITE ® | MBK1074 | MBK1074 | 2016-09-24 |
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