Identity
- Trade Name
- R-SI-LINE ® METAL-BITE ® FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- METAL-BITE ® is an universal registration material on vinyl polysiloxane base (addition curing, VPS). METAL-BITE ® 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 ® is predestined for bite plate applications of the facebow registration system and for manufacturing surgical guides for implantology. It is used successfully for the fit of para-occlusal tray adapters in CMD. METAL-BITE ® was introduced in early 2000 and has earned several awards of excellence from Reality and The Dental Advisor from 2012 to 2016. METAL-BITE ® is marketed 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
- MBK1074 FDA UDI
- Description
- METAL-BITE ® is an universal registration material on vinyl polysiloxane base (addition curing, VPS). METAL-BITE ® 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 ® is predestined for bite plate applications of the facebow registration system and for manufacturing surgical guides for implantology. It is used successfully for the fit of para-occlusal tray adapters in CMD. METAL-BITE ® was introduced in early 2000 and has earned several awards of excellence from Reality and The Dental Advisor from 2012 to 2016. METAL-BITE ® is marketed 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
- MBK1074 FDA UDI
- Primary DI / UDI-DI
- ERDEMBK10741 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 ® by R-Dental Dentalerzeugnisse GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- 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 |
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Manufacturer
- Manufacturer
- R-Dental Dentalerzeugnisse GmbH
Sources (1)
- FDA UDI 98152b0f-aec2-43cd-8f99-10095f1f7e5c 36 fields · synced May 30, 2026