Identity
- Trade Name
- EsCom100 B2 EUDAMEDEsCom100 B2 Syringe FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- EsCom100 EUDAMEDNano-hybrid universal composite resin for posterior and anterior restorations. FDA UDI
- Model / Reference
- #3102B2 EUDAMED101-0708 FDA UDI
- Description
- Nano-hybrid universal composite resin for posterior and anterior restorations. FDA UDI
Identifiers
- Catalog Number
- 101-0708 FDA UDI
- Primary DI / UDI-DI
- 08809262955279 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809262955279 EUDAMED880926295EFZP EUDAMED
- Direct Marketing DI
- 08809262955279 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
- Bulgaria 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
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
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
EsCom100 B2 by Spident — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
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- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809262955279 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809262955279 | 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 (3)
- EUDAMED 672beb5d-a41e-45f5-bf42-afa4fcc60d75 61 fields · synced Jul 31, 2026
- FDA UDI 48850867-5a17-4536-988c-88b6e8159833 35 fields · synced May 30, 2026
- EUDAMED 17a43cca-d05f-4e0f-a1c5-cc9fc51211aa 61 fields · synced Jul 11, 2026