Prosthetic Silicone Materials
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Gel Part B Catalyst - 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 FDA UDI
- Model / Reference
- M510 (100) EUDAMEDGel Part B Catalyst – 100g FDA UDI
- Description
- Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials FDA UDI
Identifiers
- Catalog Number
- M510(100) FDA UDI
- Primary DI / UDI-DI
- 05060483016108 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048301TF3D9 EUDAMED
- Direct Marketing DI
- 05060483016108 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
Similar devices
Also classified as Dental appliance fabrication material, resin.
- O-Cryl Self Curing Acrylic Shade White X 1 lb — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- PREMIUM — Lang Dental Manufacturing Company, Inc. · Class II
- Axcent Acrylics — GARRECO, LLC · Class II
- smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
- BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
- vynacron dental resins — VYNACRON DENTAL RESINS, INC. · Class II
- HI-I® — FRICKE INTERNATIONAL, INC. · Class II
- FREEPRINT crown A1 500g — DETAX GmbH · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Technovent Limited
Sources (2)
- FDA UDI 62c3dd20-f0ab-495e-a7a0-18bbbdfbaebe 35 fields · synced Jun 19, 2026
- EUDAMED 64c35b0e-4b2f-4e2b-8904-8276784b8e2f 61 fields · synced Jun 19, 2026