R-SI-LINE ® METAL-BITE ® GOLD
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Basic Information
- Brand Name
- R-SI-LINE ® METAL-BITE ® GOLD
- Primary DI
- ERDEMBK07501
- Version / Model
- MBK0750
- Catalog Number
- MBK0750
- 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
- 33a167c1-fb9b-4bc0-afc0-f9581d067a42
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.
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 | ERDEMBK07501 | HIBCC | ||||
| Unit of Use | CARTRIDGES2 | HIBCC |
Customer Contacts
- Phone
- +4940307070730
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius