← Back to catalogue
CLEARFIL SE BOND 2 Kit
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref #3270-EUModel Bondings510(k) K131432
Identity
- Trade Name
- CLEARFIL SE BOND 2 Kit EUDAMED
- Model / Reference
- Bondings EUDAMED#3270-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582110792700 EUDAMED
- Basic UDI-DI
- 458211076Bonding1954U EUDAMED
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dentine bonding agent/set
CLEARFIL SE BOND 2 Kit by Kuraray Noritake Dental Inc. Kurashiki — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Dentine bonding agent/set.
- 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
- 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 | K131432 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 458211076Bonding1954U | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kuraray Noritake Dental Inc. Kurashiki
- EUDAMED SRN
- JP-MF-000017326
- FDA Applicant
- Kuraray Noritake Dental, Inc.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 71259283-adbc-47f2-ae68-a09e7dec43c9 85 fields · synced Jun 18, 2026
- FDA 510(k) K131432 1 fields · synced May 18, 2026