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Racegel
FDA 510(k)EUDAMEDU (US FDA 510(k))
510(k) K093711Ref 287/3
by Septodont
Identity
- Trade Name
- Racegel EUDAMED
- Device Name
- Racegel EUDAMED
- Model / Reference
- 287/3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FR-MF-00001699200038PU EUDAMED
- Basic UDI-DI
- B-FR-MF-00001699200038PU EUDAMED
- 510(k) Number
- K093711 FDA 510(k)
- FDA Product Code
- MVL FDA 510(k)
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMEDU FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Racegel by Septodont — U — MDD, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | U | Active |
| FDA 510(k) | United States | FDA_510K | K093711 | U | Active |
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Manufacturer
- Manufacturer
- Septodont
Sources (2)
- FDA 510(k) K093711 24 fields · synced Jul 20, 2026
- EUDAMED 4d44ac81-3137-49e6-b5f5-5f8c4320c95b 61 fields · synced Jul 20, 2026