Identity
- Trade Name
- EsFlow LV A2 EUDAMEDEsFlow LV A2 Syringe FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- EsFlow EUDAMED
- Model / Reference
- #3304LA2 EUDAMED101-0902 FDA UDI
Identifiers
- Catalog Number
- 101-0902 FDA UDI
- Primary DI / UDI-DI
- 08809262954630 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926295FI23 EUDAMEDB-08809262954630 EUDAMED
- Direct Marketing DI
- 08809262954630 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
- Greece EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
EsFlow LV A2 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 |
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Manufacturer
- Manufacturer
- Spident Co., Ltd.
Sources (3)
- FDA UDI a2b24447-f5e0-4c35-864c-b583d08ea201 35 fields · synced Jul 11, 2026
- EUDAMED f9dbd6d6-fddf-4c7e-8791-32c65354c5cb 61 fields · synced Jul 9, 2026
- EUDAMED 9c9063e3-640f-4b9d-bc41-b01980395fd9 61 fields · synced Jul 11, 2026