Identity
- Trade Name
- reliaBond Light Cured Adhesive 5ml EUDAMEDreliaBond Xtra FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- 1 Step Bond (self etching) / 1-Part Bonding Agent EUDAMEDLC Bond Adh 5th Gen Single Pt 5ml FDA UDI
- Model / Reference
- AH1200 EUDAMEDFDA UDI
- Description
- LC Bond Adh 5th Gen Single Pt 5ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060446606216 EUDAMEDFDA UDI
- Basic UDI-DI
- 5056009120107S6 EUDAMED
- 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
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
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
reliaBond Xtra by Advanced Healthcare Ltd. — Class II — 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
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
- Advanced Healthcare Ltd.
Sources (2)
- FDA UDI 23340819-e406-492c-a52c-e0339291bd43 34 fields · synced Jun 19, 2026
- EUDAMED 430e4b31-5903-4306-9c93-19d932a9a5f2 61 fields · synced Jun 19, 2026