← Back to catalogue
EsFlow LV A3 Syringe
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref #3304A3Ref #3304LA3
Identity
- Trade Name
- EsFlow A3 EUDAMEDEsFlow LV A3 EUDAMEDEsFlow LV A3 Syringe FDA UDIEsFlow A3 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
- #3304A3 EUDAMED#3304LA3 EUDAMED101-0903 FDA UDI101-0803 FDA UDI
- Description
- Nano-hybrid Flowable composite resin for posterior and anterior restorations. FDA UDI
Identifiers
- Catalog Number
- 101-0903 FDA UDI101-0803 FDA UDI
- Primary DI / UDI-DI
- 08809262954647 EUDAMEDFDA UDI08809262954739 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926295FI23 EUDAMEDB-08809262954647 EUDAMEDB-08809262954739 EUDAMED
- Direct Marketing DI
- 08809262954739 EUDAMED08809262954647 EUDAMED
- 510(k) Number
- K120768 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
- Spain EUDAMEDGreece EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDIIn 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 UDIFDA 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 UDIFDA UDI
EsFlow LV A3 Syringe by Spident Co., Ltd. — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K120768 also covers:
- GlamaFlow Flowable Composite — TOP QUALITY MANUFACTURING, INC.
- GlamaFlow Flowable Composite — TOP QUALITY MANUFACTURING, INC.
- GlamaFlow Flowable Composite — TOP QUALITY MANUFACTURING, INC.
- GlamaFlow Flowable Composite — TOP QUALITY MANUFACTURING, INC.
- GlamaFlow Flowable Composite — TOP QUALITY MANUFACTURING, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spident Co., Ltd.
Sources (6)
- FDA UDI a5c7c8e1-bf22-47c7-bf34-a13d0f6a57cf 35 fields · synced Jul 30, 2026
- FDA UDI d09fcbe3-5562-4bbc-a329-c861f3aca5b7 35 fields · synced May 30, 2026
- EUDAMED e561a7ef-1401-439b-998b-d30fc4fc1e9a 61 fields · synced Jul 9, 2026
- EUDAMED a8b19c1f-caaa-41b8-8919-d7b58d9c78fd 61 fields · synced Jul 11, 2026
- EUDAMED 82c60805-537e-45e3-8885-4b3fff0a07e7 61 fields · synced Jul 28, 2026
- EUDAMED fc0af0cf-50da-47d8-9b8a-e142f5567b35 61 fields · synced Jul 30, 2026