Prosthetic Silicone Materials
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Softening Agent - 100g EUDAMEDProsthetic Silicone Materials FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Prosthetic Silicone Materials EUDAMEDSilicone 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
- M513 (100) EUDAMEDSoftening Agent – 100g 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(100) FDA UDI
- Primary DI / UDI-DI
- 05060483012131 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048301TF3D9 EUDAMED
- Direct Marketing DI
- 05060483012131 EUDAMED
- FDA Product Code
- GBI FDA UDI
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3800 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental appliance fabrication material, resin
Prosthetic Silicone Materials by Technovent Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Technovent Limited
Sources (2)
- FDA UDI 6240bf6a-7617-4231-9b8e-0b9fba0784f5 35 fields · synced Jun 18, 2026
- EUDAMED a2f345a4-9e3c-419b-844d-dd50f5d34c0a 61 fields · synced Jun 18, 2026