Identity
- Trade Name
- Prosthetic Silicone Materials FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials. The softening agent is an additive to reduce the hardness of cured M511 silicone rubber. The Gel Part B is an alternative cross-linker for M511 which creates a gel material, rather than a rubber. FDA UDI
- Model / Reference
- Softening Agent (50g) FDA UDI
- Description
- Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials. The softening agent is an additive to reduce the hardness of cured M511 silicone rubber. The Gel Part B is an alternative cross-linker for M511 which creates a gel material, rather than a rubber. FDA UDI
Identifiers
- Catalog Number
- M513(50) FDA UDI
- Primary DI / UDI-DI
- 05060483016245 FDA UDI
- FDA Product Code
- GBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.3800 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental appliance fabrication material, resin
Prosthetic Silicone Materials by Technovent Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Technovent Limited
Sources (1)
- FDA UDI 5a174617-b544-4e7e-a55f-45d590aeec7a 35 fields · synced Jun 8, 2026