Identity
- Trade Name
- K-Bond Universal mini EUDAMEDK-Bond Universal FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- K-Bond Universal EUDAMEDK-Bond Universal mini 2ml x 1bottle FDA UDI
- Model / Reference
- #370402 EUDAMED#370402P01 FDA UDI
- Description
- K-Bond Universal mini 2ml x 1bottle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809262956498 EUDAMEDFDA UDI
- Basic UDI-DI
- 880926295KBUT4 EUDAMED
- Direct Marketing DI
- 08809262956498 EUDAMED
- 510(k) Number
- K241445 FDA UDI
- 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
- Spain 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
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
Yes
FDA UDI
Category: Dentine bonding agent/set
K-Bond Universal by Spident Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
Cleared under the same submission
K241445 also covers:
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
- Spident Co., Ltd.
Sources (2)
- FDA UDI 12f20050-80cb-4a4e-9c56-790ca88af4aa 34 fields · synced Jul 15, 2026
- EUDAMED ea395ee0-c267-4972-8575-f00650ae8c58 61 fields · synced Jul 15, 2026