Skip to content

Klockner Kit Wt Essential

by Soadco, S.L.

Part of a family of 6 devices: see the family page

Ref KIT WT ESSENTIALModel Basic UDI

Klockner Kit Wt Essential is a device classified as Class IIa in the EU and Class II in the US made by Soadco, S.L., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 84354516TF23N3H4), cleared under FDA 510(k) K243128 on 18 Dec 2024 and listed in FDA GUDID since 14 Feb 2025 (UDI-DI 08435451608840), 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) K243128

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number84354516TF23N3H4 Basic UDI-DI 08435451608840UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435451608840 UDI-DI Date14 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243128 Date18 Dec 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 84354516TF23N3H4 registered 1 Jun 2026 Active
  • FDA 510(k) K243128 decided 18 Dec 2024 Active
  • FDA GUDID UDI-DI 08435451608840 listed 14 Feb 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243128
  2. Listed FDA GUDID 08435451608840
  3. Registered EUDAMED 84354516TF23N3H4

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Surgical Box Kit Essential® [Wt] EUDAMED
Klockner GUDID
Generic name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
KIT WT ESSENTIAL, Basic UDI
Primary DI / UDI-DI
08435451608840
Basic UDI-DI
84354516TF23N3H4
510(k) Number
FDA product code
KCT
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

Related devices

Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Cleared under the same submission (K243128)

and 8 more cleared under K243128

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

  • Sterilise before use
  • Reusable
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)