Identity
- Trade Name
- EsCom100 TW EUDAMEDEsCom 100 TW Syringe FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- EsCom100 EUDAMED
- Model / Reference
- #3102TW EUDAMED101-0711 FDA UDI
Identifiers
- Catalog Number
- 101-0711 FDA UDI
- Primary DI / UDI-DI
- 08809262955323 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809262955323 EUDAMED880926295EFZP EUDAMED
- Direct Marketing DI
- 08809262955323 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
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
No
FDA UDI
Category: Dental composite resin
EsCom100 TW by Spident — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
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- 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-08809262955323 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809262955323 | 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 4aab5eae-5ee0-4f1d-bd09-078f02711ffa 61 fields · synced Jul 29, 2026
- FDA UDI e9deee29-06da-47f3-8236-14b5e976eb7a 34 fields · synced May 30, 2026
- EUDAMED 6ebb772b-c3b1-4459-8f84-6170369fe3b4 61 fields · synced Jun 14, 2026