Identity
- Trade Name
- EsBond refill EUDAMEDEsBond FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- EsBond EUDAMED5th Generation Bonding. Light Cured, single bottle application bonding system. FDA UDI
- Model / Reference
- #370200 EUDAMED101-0501 FDA UDI
- Description
- 5th Generation Bonding. Light Cured, single bottle application bonding system. FDA UDI
Identifiers
- Catalog Number
- 101-0501 FDA UDI
- Primary DI / UDI-DI
- 08809262955415 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926295EBZF EUDAMEDB-08809262955415 EUDAMED
- Direct Marketing DI
- 08809262955415 EUDAMED
- 510(k) Number
- K120767 FDA UDI
- FDA Product Code
- KLE FDA UDI
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3200 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
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: Dentine bonding agent/set
EsBond by Spident Co., Ltd. — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 200b3ebf-f00a-4479-a76b-270843aa3c04 36 fields · synced Jun 19, 2026
- EUDAMED d3b3d715-33c9-405a-ada7-306a42f64de8 61 fields · synced Jun 18, 2026
- EUDAMED 76da0dbd-19b0-4235-9252-bf8391ec3300 61 fields · synced Jun 19, 2026