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Klockner 19 31 08

by Soadco, S.L.

Part of a family of 203 devices: see the family page

Ref 19 31 08Model Basic UDI

Klockner 19 31 08 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 84354516TF01QA), cleared under FDA 510(k) K153098 on 8 Apr 2016 and listed in FDA GUDID since 12 Feb 2025 (UDI-DI 08435451623096), 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) K153098

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 Number84354516TF01QA Basic UDI-DI 08435451623096UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435451623096 UDI-DI Date12 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK153098 Date8 Apr 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 84354516TF01QA registered 1 Jun 2026 Active
  • FDA 510(k) K153098 decided 8 Apr 2016 Active
  • FDA GUDID UDI-DI 08435451623096 listed 12 Feb 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153098
  2. Listed FDA GUDID 08435451623096
  3. Registered EUDAMED 84354516TF01QA

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  • Withdrawn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
Vega®+ Mv Implant Ø3.1 X 08mm EUDAMED
Klockner GUDID
Generic name
Screw endosteal dental implant, one-piece
Model / Ref / Catalog
19 31 08, Basic UDI
Primary DI / UDI-DI
08435451623096 EUDAMED
08435451600042 GUDID
Basic UDI-DI
84354516TF01QA
510(k) Number
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Screw endosteal dental implant, one-piece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08435451623096
GUDID
08435451600042
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08435451623096; FDA GUDID lists 08435451600042), so their flags are not compared. 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: Screw endosteal dental implant, one-piece

Cleared under the same submission (K153098)

and 8 more cleared under K153098

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)