Composite Universal Fotopolimerizable Syringe C2
EUDAMEDFDA UDIClass IIa (EU MDR)
by Spident
Identity
- Trade Name
- COMPOSITE UNIVERSAL FOTOPOLIMERIZABLE SYRINGE C2 EUDAMEDEsCom100 A3 EUDAMEDEsCom100 A3 Syringe FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- EsCom250 EUDAMEDEscom100 EUDAMEDNano-hybrid universal composite resin for posterior and anterior restorations. FDA UDI
- Model / Reference
- 63638 EUDAMED#3102A3 EUDAMED101-0703 FDA UDI
- Description
- Nano-hybrid universal composite resin for posterior and anterior restorations. FDA UDI
Identifiers
- Catalog Number
- 101-0703 FDA UDI
- Primary DI / UDI-DI
- 08809262955231 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926295ECMRR EUDAMEDB-08809262955231 EUDAMED880926295EFZP EUDAMED
- Direct Marketing DI
- 08809262955231 EUDAMED
- 510(k) Number
- K110428 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Spain EUDAMEDBulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
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
No
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: Dental composite resin
Composite Universal Fotopolimerizable Syringe C2 by Spident — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 880926295ECMRR | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 880926295ECMRR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Spident
- EUDAMED SRN
- KR-MF-000008691
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (4)
- EUDAMED aa37b8ee-3b5a-4a8d-9aca-bd184f0ace0c 61 fields · synced Jun 20, 2026
- EUDAMED ac03e909-9ee8-4869-8109-a627f4a4467e 61 fields · synced May 18, 2026
- FDA UDI 64f080b7-7122-4ae0-b584-893963a21190 36 fields · synced May 30, 2026
- EUDAMED 8124549a-a2ca-4976-9ee4-bbe414a7eba9 61 fields · synced Jun 20, 2026