R-SI-LINE ® METAL-BITE ® GOLD
- Primary DI
- ERDEMBK07501
- Brand
- R-SI-LINE ® METAL-BITE ® GOLD
- Company
- R-Dental Dentalerzeugnisse GmbH
- Model
- MBK0750
- Catalog number
- MBK0750
- Device description
- METAL-BITE ® GOLD is an universal and scannable registration material on vinyl polysiloxane base (addition curing, VPS). METAL-BITE ® GOLD is extremely fast, hard and thixotropic. It is easy to trim, very suitable for cutting and contouring. The material has no taste at all, is radiopaque and offers an excellent dimension stability. Further on METAL-BITE ® GOLD is optimzed for CEREC 3D, the contrast of METAL-BITE ® GOLD has been increased and offers brilliant antagonist data. It is predestined for dynamic registrations according to FGP methods and classical facebow registrations. The registrations can then be scanned. METAL-BITE ® GOLD was introduced in 2005. METAL-BITE ® GOLD is marketed in many countries worldwide. The product is available in standard 50 ml auto-mixing cartridges plus 12 mixing cannulas and 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 |
|---|
| ERDEMBK07501 | 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 |
| ERDEMBK10741 | R-SI-LINE ® METAL-BITE ® | MBK1074 | MBK1074 | 2016-09-24 |
| ERDEMOK04751 | R-SI-LINE ® MONO S SCAN | MOK0475 | MOK0475 | 2016-09-24 |
Other Devices Sharing Product Codes
r-dental.com