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One-Fil

by MEDICLUS Co., Ltd.

Ref GB2021OC005Model OS2GBX1S, CanalPro CalciSeal, 508-1 One-Fil, 508-2 One-Fil 0.5, 509-1 One-Fil Putty Injectable, 508-8 CanalPro CalciSeal

One-Fil (GB2021OC005) is a hygroscopic dental cement (EU MDR Class IIa; FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by MEDICLUS Co., Ltd., cleared under FDA 510(k) K251884 on 22 Aug 2025 (2 earlier submissions), registered in EUDAMED on 17 May 2024 (Basic UDI-DI B-08809518341252) and listed in FDA GUDID since 23 Apr 2026 (UDI-DI 08809518341252), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251884

+2 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809518341252 UDI-DI Date23 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK251884 Date22 Aug 2025DecidedStatusActive
United StatesFDA 510(k) 510(k) NumberK243353 Date14 Mar 2025IssuedStatusActive
European UnionCE/MDR EUDAMED NumberB-08809518341252 Basic UDI-DI Date17 May 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08809518341252 Basic UDI-DI Date17 May 2024RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K251884 decided 22 Aug 2025 Active· +2 more in the status table
  • EUDAMED Basic UDI-DI B-08809518341252 registered 17 May 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08809518341252 listed 23 Apr 2026 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K232182
  2. Registered EUDAMED B-08809518341252
  3. Cleared FDA 510(k) K243353
  4. Cleared FDA 510(k) K251884
  5. Listed FDA GUDID 08809518341252

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
One-Fil EUDAMEDGUDID
CanalPro CalciSeal GUDID
One-Fil Putty Injectable GUDID
Generic name
Hygroscopic dental cement
Device name
Bioceramic root canal sealer
Model / Ref / Catalog
OS2GBX1S, CanalPro CalciSeal, GB2021OC005, 508-1 One-Fil, 508-2 One-Fil 0.5, 509-1 One-Fil Putty Injectable, 508-8 CanalPro CalciSeal, 60043033, EC2501001
Primary DI / UDI-DI
08809518341252, 08809518341269, 08809518346608, 08809518345106
Basic UDI-DI
B-08809518341252, 880951834EN03JV
Direct marketing DI
08809518341269
08809518346608
08809518341252
08809518345106
510(k) Number
FDA product code
KIF
EMDN code
Q01010201, Q01010299
GMDN term
Hygroscopic dental cement
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3820
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Italy
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 2 Gram
Weight — 0.5 Gram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
KR-MF-000022584
Authorised representative
KTR Europe GmbH DE-AR-000005685

Related devices

Category: Dental coating, tooth-desensitizing

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DENTAL PASTES.

Other devices from MEDICLUS Co., Ltd.

See all devices from MEDICLUS Co., Ltd. →

Properties

  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)