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Ceramic Bond
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1106Ref 1107
by VOCO GmbH
Identity
- Trade Name
- Ceramic Bond EUDAMEDFDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Ceramic Bond EUDAMED
- Model / Reference
- 1106 EUDAMEDFDA UDI1107 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- E22111061 EUDAMEDFDA UDIE22111071 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210236000000000CN EUDAMED
- 510(k) Number
- K062345 FDA UDI
- FDA Product Code
- EBF 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
- 872.3690 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
Ceramic Bond by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Dentine bonding agent/set.
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- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062345 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210236000000000CN | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (5)
- EUDAMED 43b0622b-2f25-4c38-85ab-b07e0b49e512 61 fields · synced Jul 9, 2026
- FDA UDI be7baef5-72b3-469a-b7f1-1d4b9040a560 34 fields · synced May 30, 2026
- FDA UDI f10bf395-0258-4141-a1d6-19013676eaf3 34 fields · synced May 30, 2026
- EUDAMED 208d5e89-b7f4-49a8-a980-552c0836dfe2 61 fields · synced Jul 9, 2026
- FDA 510(k) K062345 1 fields · synced May 18, 2026