Identity
- Trade Name
- Coform Soft-40g EUDAMEDProsthetic Silicone Materials FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Prosthetic Silicone Materials EUDAMEDCartridge based silicone materials for taking external impressions to aid the construction of prostheses. FDA UDI
- Model / Reference
- M517 EUDAMEDCoForm Soft Impression Material – 40g FDA UDI
- Description
- Cartridge based silicone materials for taking external impressions to aid the construction of prostheses. FDA UDI
Identifiers
- Catalog Number
- M517 FDA UDI
- Primary DI / UDI-DI
- 05060483012452 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048301TF3D9 EUDAMED
- Direct Marketing DI
- 05060483012452 EUDAMED
- FDA Product Code
- GBI FDA UDI
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
- GMDN Term
- Silicone dental impression material 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: Silicone dental impression material
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 Silicone dental impression material.
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- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
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 cd7c1ba7-20fa-4596-8eed-ae83759005b2 35 fields · synced Jul 11, 2026
- EUDAMED 549c675e-68e3-42b2-b91c-d246bd8f0b65 61 fields · synced Jul 11, 2026