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Klockner 10 06 21 P

by Soadco, S.L.

Ref 10 06 21 PModel Basic UDI

Klockner 10 06 21 P is a device classified as Class I in the EU and Class II in the US made by Soadco, S.L., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 84354516TF19N1HP), cleared under FDA 510(k) K173642 on 2 Oct 2018 and listed in FDA GUDID since 22 Nov 2022 (UDI-DI 08435451629296), 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) K173642

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 Number84354516TF19N1HP Basic UDI-DI 08435451629296UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435451629296 UDI-DI Date22 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK173642 Date2 Oct 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 84354516TF19N1HP registered 1 Jun 2026 Active
  • FDA 510(k) K173642 decided 2 Oct 2018 Active
  • FDA GUDID UDI-DI 08435451629296 listed 22 Nov 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173642
  2. Listed FDA GUDID 08435451629296
  3. Registered EUDAMED 84354516TF19N1HP

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  • Withdrawn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 Klockner® Internal [Empty] EUDAMED
Klockner GUDID
Generic name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
10 06 21 P, Basic UDI
Primary DI / UDI-DI
08435451629296
Basic UDI-DI
84354516TF19N1HP
510(k) Number
FDA product code
KCT
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device class
Class I 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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08435451629296: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I 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 (K173642)

and 8 more cleared under K173642

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)