Speedex
FDA UDIEUDAMEDClass II (US FDA UDI)
by Dent4You AG
Identity
- Trade Name
- Speedex medium 1 x 140 ml EM EUDAMEDSPEEDEX FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- SPEEDEX MEDIUM SGL 140ML FDA UDI
- Model / Reference
- 4986 EM EUDAMEDFDA UDISpeedex EUDAMED
- Description
- SPEEDEX MEDIUM SGL 140ML FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630243601738 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929CSIL190114J EUDAMED
- 510(k) Number
- K242360 FDA UDI
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Silicone dental impression material
Speedex by Dent4You AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K242360 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
Sources (2)
- FDA UDI 28035982-1b16-4188-87fe-c73c621a2f34 34 fields · synced Jul 27, 2026
- EUDAMED 19e9f1f4-b359-4cb7-87aa-94e389f2d8f4 61 fields · synced Jul 27, 2026