R-SI-LINE ® MONO S SCAN
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Basic Information
- Brand Name
- R-SI-LINE ® MONO S SCAN
- Primary DI
- ERDEMOK04751
- Version / Model
- MOK0475
- Catalog Number
- MOK0475
- Company Name
- R-Dental Dentalerzeugnisse GmbH
- Labeler DUNS
- 313956880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-04-10
- Public Version Status
- Update
- Public Device Record Key
- 8086641c-3bed-496e-a7f2-5bcb1ba613de
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ERDEMOK04751 | HIBCC | ||||
| Unit of Use | CARTRIDGES2 | HIBCC |
Customer Contacts
- Phone
- +4940307070730
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius