Identity
- Trade Name
- EsFlow PLUS A1 EUDAMEDEsFlow PLUS FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- EsFlow PLUS EUDAMEDEsFlow PLUS A1 2.5g x 1sy FDA UDI
- Model / Reference
- #3306A1P01 EUDAMEDFDA UDI
- Description
- EsFlow PLUS A1 2.5g x 1sy FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809262950212 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926295SEPUB EUDAMED
- Direct Marketing DI
- 08809262950212 EUDAMED
- 510(k) Number
- K250317 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
- Greece 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
Yes
FDA UDI
Category: Dental composite resin
EsFlow PLUS by Spident Co., Ltd. — Class II — MDR, 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
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- 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
Cleared under the same submission
K250317 also covers:
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
- EsFlow PLUS — Spident Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (2)
- FDA UDI 06ef84f2-23bc-4cf3-8c40-8f055e703a0d 34 fields · synced Jun 18, 2026
- EUDAMED 0a098cc4-8660-4462-9318-3317fe78baf4 61 fields · synced Jun 18, 2026