# One-Fil

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/one-fil-gb2021oc005>
- Manufacturer: [MEDICLUS Co., Ltd.](https://devicerts.com/manufacturers/mediclus-co-ltd) (South Korea)
- Device class: Class IIa (EU MDR / EU MDD); Class II (US FDA)
- FDA product code: KIF
- EMDN: Q01010201 ROOT CANAL FILLING DENTAL PASTES
- EMDN: Q01010299 ROOT CANAL FILLING DEVICES - OTHER
- GMDN: Hygroscopic dental cement (60510)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 08809518341252 · listed 2026-04-23 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K251884 · decision 2025-08-22 · decision SESE · status: Active · from GUDID
- **510(k)** · FDA 510(k) · United States · K243353 · issued 2025-03-14 · status: Active
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI B-08809518341252 · registered 2024-05-17 · status: Active
- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-08809518341252 · registered 2024-05-17 · status: Active
- **510(k)** · FDA 510(k) · United States · K232182 · issued 2024-01-26 · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: One-Fil [EUDAMED, FDA GUDID (AccessGUDID)]; CanalPro CalciSeal [FDA GUDID (AccessGUDID)]; One-Fil Putty Injectable [FDA GUDID (AccessGUDID)]
- Generic name: Hygroscopic dental cement [FDA GUDID (AccessGUDID)]
- Device name: Bioceramic root canal sealer [EUDAMED]
- Model / Ref / Catalog: OS2GBX1S [EUDAMED]; CanalPro CalciSeal [EUDAMED]; GB2021OC005 [EUDAMED]; 508-1 One-Fil [EUDAMED, FDA GUDID (AccessGUDID)]; 508-2 One-Fil 0.5 [EUDAMED]; 509-1 One-Fil Putty Injectable [EUDAMED, FDA GUDID (AccessGUDID)]; 508-8 CanalPro CalciSeal [EUDAMED]; 60043033 [FDA GUDID (AccessGUDID)]; EC2501001 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08809518341252 [EUDAMED, FDA GUDID (AccessGUDID)]; 08809518341269 [EUDAMED]; 08809518346608 [EUDAMED, FDA GUDID (AccessGUDID)]; 08809518345106 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-08809518341252 [EUDAMED]; 880951834EN03JV [EUDAMED]
- Direct marketing DI: 08809518341269 [EUDAMED]; 08809518346608 [EUDAMED]; 08809518341252 [EUDAMED]; 08809518345106 [EUDAMED]
- 510(k) Number: K232182 [FDA GUDID (AccessGUDID)]; K251884 [FDA GUDID (AccessGUDID)]
- FDA product code: KIF [FDA GUDID (AccessGUDID)]
- EMDN code: Q01010201 [EUDAMED]; Q01010299 [EUDAMED]
- GMDN term: Hygroscopic dental cement (60510) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 872.3820 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]; Standard device [EUDAMED]
- EU market of registration: Italy [EUDAMED]; Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Weight — 2 Gram [FDA GUDID (AccessGUDID)]; Weight — 0.5 Gram [FDA GUDID (AccessGUDID)]

## Properties

- Implantable: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: One-Fil, MEDICLUS Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/one-fil-gb2021oc005 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/one-fil-gb2021oc005.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/one-fil-gb2021oc005
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.