Identity
- Trade Name
- R-SI-LINE ® METAL-BITE ® GOLD FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MBK0750 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- MBK0750 FDA UDI
- Primary DI / UDI-DI
- ERDEMBK07501 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Silicone dental impression material
R-Si-Line ® Metal-Bite ® Gold by R-Dental Dentalerzeugnisse GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- R-Dental Dentalerzeugnisse GmbH
Sources (1)
- FDA UDI 33a167c1-fb9b-4bc0-afc0-f9581d067a42 36 fields · synced Jun 8, 2026