Any-Paste

Ref GB2021OC005Model 505-1 Any-Paste

Any-Paste (GB2021OC005) is an endodontic temporary cement (EU MDR Class IIa; FDA Class II; FDA product code KIF, Resin, Root Canal Filling) made by MEDICLUS Co., Ltd., registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 880951834EN07K5), cleared under FDA 510(k) K253167 on 12 Jan 2026 and listed in FDA GUDID since 1 Jun 2026 (UDI-DI 08809518341511), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253167

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number880951834EN07K5 Basic UDI-DI 08809518341511UDI-DI	Date21 Aug 2026Registered	StatusActive
United States	GUDID listing GUDID	Number08809518341511 UDI-DI	Date1 Jun 2026Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK253167	Date12 Jan 2026Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI 880951834EN07K5 — open Devices and search for it
AccessGUDID record UDI-DI 08809518341511
FDA 510(k) database 510(k) number K253167

Across registries

3 registries list this device

EUDAMED Basic UDI-DI 880951834EN07K5 registered 21 Aug 2026 Active
FDA 510(k) K253167 decided 12 Jan 2026 Active
FDA GUDID UDI-DI 08809518341511 listed 1 Jun 2026 Listed

Timeline

3 dated events

12 Jan 2026 Cleared FDA 510(k) K253167
1 Jun 2026 Listed FDA GUDID 08809518341511
21 Aug 2026 Registered EUDAMED 880951834EN07K5

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name: Endodontic temporary cement
Device name: Dental temporary filling material
Model / Ref / Catalog: 505-1 Any-Paste EUDAMED
GB2021OC005 EUDAMED
505-1 GUDID
EC2501001 GUDID

Primary DI / UDI-DI: 08809518341511
Basic UDI-DI: 880951834EN07K5
Direct marketing DI: 08809518341511
510(k) Number: K253167
FDA product code: KIF
EMDN code: Q01010201 Root canal filling dental pastes
GMDN term: Endodontic temporary cement

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 872.3820
EU registration type: Standard device
EU market of registration: Croatia
GUDID distribution status: In Commercial Distribution

Size: Weight — 2 Gram

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED 505-1 Any-Paste GB2021OC005	GUDID 505-1
Device class	EUDAMED 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

Similar devices in this category

Other devices filed under ROOT CANAL FILLING DENTAL PASTES.

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See all devices from MEDICLUS Co., Ltd. →

Properties

Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (21, all answered No)