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One-Fil PT

by MEDICLUS Co., Ltd.

Ref GB2021OC005(012022), GB2021OC005Model 509-2 One-Fil Putty, 509-3 One-Fil Putty, 509-2 One-Fil PUTTY 0.25G4S, 509-6 One-Fil PUTTY 0.5G2S

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809518343706 UDI-DI Date11 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberB-08809518343706 Basic UDI-DI Date5 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
One-Fil PT EUDAMED
One-Fil Putty GUDID
Generic Name
Hygroscopic dental cement
Device Name
Bioceramic root canal sealer
Model / Ref / Catalog
509-2 One-Fil Putty, 509-3 One-Fil Putty, GB2021OC005(012022), 509-2 One-Fil PUTTY 0.25G4S, 509-6 One-Fil PUTTY 0.5G2S, GB2021OC005, EC2501001
Primary DI / UDI-DI
08809518343706, 08809518346899
Basic UDI-DI
B-08809518343706, 880951834EN04JX
Direct Marketing DI
08809518346899
08809518343706
510(k) Number
FDA Product Code
KIF
EMDN Code
Q01010299 Root canal filling devices - other
GMDN Term
Hygroscopic dental cement
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3820
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.25 Gram

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
509-2 One-Fil Putty, 509-3 One-Fil Putty
GB2021OC005(012022)
509-2 One-Fil PUTTY 0.25G4S, 509-6 One-Fil PUTTY 0.5G2S
GB2021OC005
GUDID
509-2 One-Fil Putty
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
Yes
GUDID
Yes

Manufacturer details

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

Other devices from MEDICLUS Co., Ltd.

See all devices from MEDICLUS Co., Ltd. →

Properties

  • Implantable NoEUDAMEDYesEUDAMEDGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No