Identity
- Trade Name
- Futurabond U EUDAMEDFDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Futurabond U EUDAMEDDual-curing universal adhesive. FDA UDI
- Model / Reference
- 1576 EUDAMEDFDA UDI
- Description
- Dual-curing universal adhesive. FDA UDI
Identifiers
- Catalog Number
- 1576 FDA UDI
- Primary DI / UDI-DI
- +E22115761 EUDAMEDE22115761 FDA UDI
- Basic UDI-DI
- ++E2210639000000000KZ EUDAMED
- 510(k) Number
- K130486 FDA UDI
- FDA Product Code
- KLE FDA UDIEMA 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 UDI872.3275 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Category: Dentine bonding agent/set
Futurabond U by VOCO GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dentine bonding agent/set.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E2210639000000000KZ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210639000000000KZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (2)
- EUDAMED 179edb63-bd65-442d-8345-c51c79430fb9 61 fields · synced May 31, 2026
- FDA UDI b873fceb-94bd-45f8-acdf-b0d6b9ea516b 37 fields · synced May 30, 2026