Identity
- Trade Name
- Smartcord 03 EUDAMED
- Device Name
- Gingival Retraction Cord EUDAMED
- Model / Reference
- Smartcord EUDAMEDEDSC-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809370410059 EUDAMED
- Basic UDI-DI
- 880937041001177 EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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: Gingival retraction cord, non-medicated
Smartcord 03 by EASTDENT Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Gingival retraction cord, non-medicated.
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- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I
- Mouth Prop — Huanghua Promisee Dental Co.Ltd. · Class I
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 | K171577 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 880937041001177 | Class I | Active |
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Manufacturer
- Manufacturer
- EASTDENT Co., Ltd
- EUDAMED SRN
- KR-MF-000022583
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED e1b43e47-2946-41b9-9b63-10f83f9fe692 61 fields · synced Jun 18, 2026
- FDA 510(k) K171577 1 fields · synced May 18, 2026