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One-Fil
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref GB2021OC005Model OS2GBX1S, CanalPro CalciSealRef GB2021OC005(012022)Model 509-2 One-Fil Putty, 509-3 One-Fil Putty
Identity
- Trade Name
- One-Fil EUDAMEDOne-Fil PT EUDAMED
- Device Name
- One-Fil EUDAMEDOne-Fil Putty EUDAMED
- Model / Reference
- OS2GBX1S, CanalPro CalciSeal EUDAMEDGB2021OC005 EUDAMED509-2 One-Fil Putty, 509-3 One-Fil Putty EUDAMEDGB2021OC005(012022) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809518341252 EUDAMED08809518343706 EUDAMED
- Basic UDI-DI
- B-08809518341252 EUDAMEDB-08809518343706 EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMEDQ01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
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
Category: Dental coating, tooth-desensitizing
One-Fil by MEDICLUS Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243353 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232182 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809518341252 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MEDICLUS Co., Ltd.
- EUDAMED SRN
- KR-MF-000022584
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED ccd41e21-cd9f-4e09-b05b-ef9da4e4d884 61 fields · synced Aug 4, 2026
- EUDAMED 2c12817c-c001-46ca-88b2-e568f283cd53 61 fields · synced May 17, 2026
- FDA 510(k) K243353 1 fields · synced May 18, 2026