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Klockner Kit Wt Interna

by Soadco, S.L.

Klockner Kit Wt Interna is a Class II device made by Soadco, S.L., cleared under FDA 510(k) K243128 on 18 Dec 2024 and listed in FDA GUDID since 14 Feb 2025 (UDI-DI 08435451637956), 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) K243128

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 Number08435451637956 UDI-DI Date14 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243128 Date18 Dec 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243128 decided 18 Dec 2024 Active
  • FDA GUDID UDI-DI 08435451637956 listed 14 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243128
  2. Listed FDA GUDID 08435451637956

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  • Withdrawn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
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
KIT WT INTERNA
Primary DI / UDI-DI
08435451637956
510(k) Number
FDA product code
KCT
GMDN term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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 Dental/maxillofacial surgical procedure kit, non-medicated, reusable.

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

  • Sterilise before use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)