Skip to content

CleaniCal

by Maruchi

Ref 00017

CleaniCal (00017) is a device classified as Class IIa in the EU and Class II in the US made by Maruchi, registered in EUDAMED on 29 Jul 2025 (Basic UDI-DI 8800071200017UJ), cleared under FDA 510(k) K201799 on 12 Feb 2021 and listed in FDA GUDID since 16 May 2023 (UDI-DI 08800071200017), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201799↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8800071200017UJ Basic UDI-DI 08800071200017UDI-DIDate29 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08800071200017 UDI-DI Date16 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK201799 Date12 Feb 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8800071200017UJ registered 29 Jul 2025 Active
  • FDA 510(k) K201799 decided 12 Feb 2021 Active
  • FDA GUDID UDI-DI 08800071200017 listed 16 May 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201799
  2. Listed FDA GUDID 08800071200017
  3. Registered EUDAMED 8800071200017UJ

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Endodontic temporary cement
Model / reference
00017 EUDAMED
CleaniCal GUDID
Primary DI / UDI-DI
08800071200017
Basic UDI-DI
8800071200017UJ
510(k) Number
FDA product code
KIF, EJK
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, 872.3250
EU registration type
Standard device
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00017
GUDID
CleaniCal
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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-000030192
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 Maruchi

See all devices from Maruchi →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)