Identity
- Trade Name
- EsFlow A1 EUDAMEDEsFlow A1 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
- #3304A1 EUDAMED101-0801 FDA UDI
- Description
- Nano-hybrid Flowable composite resin for posterior and anterior restorations. FDA UDI
Identifiers
- Catalog Number
- 101-0801 FDA UDI
- Primary DI / UDI-DI
- 08809262954715 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926295FI23 EUDAMEDB-08809262954715 EUDAMED
- Direct Marketing DI
- 08809262954715 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 A1 Syringe by Spident Co., Ltd. — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
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- 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 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 1c71b868-d4b8-44c1-a576-f8eea0f6a63b 35 fields · synced Jul 30, 2026
- EUDAMED e048ce03-c691-49c7-81f8-6009a9488f8e 61 fields · synced Jul 29, 2026
- EUDAMED 7d398181-0d0b-4c9f-896e-da09af7a4618 61 fields · synced Jul 30, 2026