Identity
- Trade Name
- ZOO4-500g Silicone Rubber 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 High Consistency Rubber (HCR) Prosthetic Silicones (1:1) are a range of 2 parts (A and B) silicone rubber materials for prosthetic use which are mixed 1:1 by weight ratio A:B. FDA UDI
- Model / Reference
- ZOO4-500g EUDAMEDHigh Strength Silicone Rubber – 500g FDA UDI
- Description
- Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials. The High Consistency Rubber (HCR) Prosthetic Silicones (1:1) are a range of 2 parts (A and B) silicone rubber materials for prosthetic use which are mixed 1:1 by weight ratio A:B. FDA UDI
Identifiers
- Catalog Number
- Z004(500g) FDA UDI
- Primary DI / UDI-DI
- 05060483012100 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048301TF3D9 EUDAMED
- Direct Marketing DI
- 05060483012100 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 0f3c4715-9808-4f8a-9cbe-a1c7a66076e1 35 fields · synced Jun 19, 2026
- EUDAMED 341ae113-9fd3-4ff6-acf4-7b6b99ec7fb0 61 fields · synced Jun 19, 2026