Identity
- Trade Name
- EsFlow A3.5 EUDAMEDEsFlow A3.5 Syringe FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- EsFlow EUDAMEDNano-hybrid Flowable composite resin for posterior and anterior restorations. FDA UDI
- Model / Reference
- #3304A35 EUDAMED101-0804 FDA UDI
- Description
- Nano-hybrid Flowable composite resin for posterior and anterior restorations. FDA UDI
Identifiers
- Catalog Number
- 101-0804 FDA UDI
- Primary DI / UDI-DI
- 08809262954746 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926295FI23 EUDAMEDB-08809262954746 EUDAMED
- Direct Marketing DI
- 08809262954746 EUDAMED
- 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 EUDAMEDGreece 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
EsFlow A3.5 Syringe by Spident Co., Ltd. — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| 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
- Spident Co., Ltd.
Sources (3)
- FDA UDI 826c8d17-e332-402a-aa44-d72527b1e79f 35 fields · synced Jul 10, 2026
- EUDAMED d8398488-815c-4a7b-b94c-d2bd512b28d5 61 fields · synced Jul 9, 2026
- EUDAMED 0c9d0a21-942c-4e57-8268-e586f8baaaec 61 fields · synced Jul 10, 2026