Identity
- Trade Name
- Single Bonding 3ml EUDAMEDSINGLE BONDING FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Dental Adhesive EUDAMEDSingle Bonding (Light Cure) FDA UDI
- Model / Reference
- 130106003 EUDAMED3ml FDA UDI
- Description
- Single Bonding (Light Cure) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05206569760019 EUDAMEDFDA UDI
- Basic UDI-DI
- 5206569COTH52SN 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
- 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
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
Single Bonding by Dmp Dental Industry S.a. — 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
- Dmp Dental Industry S.a.
Sources (2)
- FDA UDI e75910fb-a008-4049-8e65-bded33512007 35 fields · synced Jun 19, 2026
- EUDAMED 8676c2f5-f14d-4565-b81f-9cc43d87dddf 61 fields · synced Jun 19, 2026