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Klockner 18 16 34

by Soadco, S.L.

Klockner 18 16 34 is a Class II device made by Soadco, S.L., cleared under FDA 510(k) K230103 on 24 Apr 2023 and listed in FDA GUDID since 13 Jun 2023 (UDI-DI 08435451635013), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K230103

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08435451635013 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK230103 Date24 Apr 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K230103 decided 24 Apr 2023 Active
  • FDA GUDID UDI-DI 08435451635013 listed 13 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K230103
  2. Listed FDA GUDID 08435451635013

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Klockner
Generic name
Overdenture
Model / Ref / Catalog
18 16 34
Primary DI / UDI-DI
08435451635013
510(k) Number
FDA product code
NHA
GMDN term
Overdenture
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Overdenture

Cleared under the same submission (K230103)

and 8 more cleared under K230103

Similar devices

Also classified as Overdenture.

Similar devices

Other devices filed under FDA product code NHA (Abutment, implant, dental, endosseous).

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

  • Sterilise before use
  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)