Identity
- Trade Name
- Speedcem Plus Refill 3x9g yellow EUDAMEDSpeedCEM / SpeedCEM Plus FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Multilink Speed, SpeedCEM, SpeedCEM Plus, Speedcem 100 EUDAMEDSpeedcem Plus Refill 3x9g yellow FDA UDI
- Model / Reference
- 692423WW EUDAMEDFDA UDI
- Description
- Speedcem Plus Refill 3x9g yellow FDA UDI
Identifiers
- Catalog Number
- 692423WW FDA UDI
- Primary DI / UDI-DI
- 07615208293470 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082ACEME002DX EUDAMED
- Unit of Use DI
- 07615208480016 EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
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
Yes
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
No
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 composite resin
SpeedCEM / SpeedCEM Plus by Ivoclar Vivadent Aktiengesellschaft — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (2)
- FDA UDI 2290e8de-eddd-4255-922b-9d31719c450b 34 fields · synced Jul 12, 2026
- EUDAMED c06cf0e1-0e60-4a55-9b15-9a4fe9c97577 61 fields · synced Jul 12, 2026