Identity
- Trade Name
- EsFlow B2 EUDAMEDEsFlow B2 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
- #3304B2 EUDAMED101-0805 FDA UDI
- Description
- Nano-hybrid Flowable composite resin for posterior and anterior restorations. FDA UDI
Identifiers
- Catalog Number
- 101-0805 FDA UDI
- Primary DI / UDI-DI
- 08809262954760 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809262954760 EUDAMED880926295FI23 EUDAMED
- Direct Marketing DI
- 08809262954760 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
- Greece EUDAMEDSpain 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 B2 Syringe by Spident Co., Ltd. — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
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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 Unknown
MDR
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| EUDAMED | European Union | MDD | — | 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 5924ec5e-a1f9-49c4-8d0e-1866aeebc7cb 35 fields · synced Jul 12, 2026
- EUDAMED 3f5deea6-c5df-4e5f-accd-e56f2a650c02 61 fields · synced Jul 11, 2026
- EUDAMED 9cdef7fe-133a-4d85-88b3-44dd9198f478 61 fields · synced Jul 12, 2026