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Klockner 82 12 01 G

by Soadco, S.L.

Part of a family of 61 devices: see the family page

Ref 82 12 01 GModel Basic UDI

Klockner 82 12 01 G is a device classified as Class IIb in the EU and Class II in the US made by Soadco, S.L., registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 84354516TF99RM), cleared under FDA 510(k) K010132 on 4 Jun 2002 and listed in FDA GUDID since 12 Feb 2025 (UDI-DI 08435451650573), 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) K010132

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 Number84354516TF99RM Basic UDI-DI 08435451650573UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435451650573 UDI-DI Date12 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK010132 Date4 Jun 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 84354516TF99RM registered 1 Jun 2026 Active
  • FDA 510(k) K010132 decided 4 Jun 2002 Active
  • FDA GUDID UDI-DI 08435451650573 listed 12 Feb 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K010132
  2. Listed FDA GUDID 08435451650573
  3. Registered EUDAMED 84354516TF99RM

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  • Withdrawn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
Hexagonal Castable Abutment Ø5.5mm Set [Hexagonal Screw] EUDAMED
Klockner GUDID
Generic name
Dental implant suprastructure kit
Model / Ref / Catalog
82 12 01 G, Basic UDI
Primary DI / UDI-DI
08435451650573
Basic UDI-DI
84354516TF99RM
510(k) Number
FDA product code
NHA
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure kit
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
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 · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes
ImplantableEUDAMED
Yes
GUDID
No

Registry differences

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

  • Sterilise before use UDI-DI 08435451650573: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb 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 implant suprastructure kit

Cleared under the same submission (K010132)

and 8 more cleared under K010132

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)