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Klockner Kits

by Soadco, S.L.

510(k) K243128

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243128 Date18 Dec 2024ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KCT
Device class
Class II
Regulation
21 CFR Part 880.6850
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Klockner Kits are a set of dental surgical instruments and accessories designed for use in implantology procedures. These kits provide essential tools for preparing implant sites, placing dental implants, and ensuring precise surgical outcomes in general hospital settings. The device type aligns with dental implant-related instrumentation, supporting orthopedic and maxillofacial applications.

These kits are supplied as a reusable set and are intended for single-use per procedure, adhering to standard surgical hygiene protocols. They are not classified as MRI-safe or MRI-conditional, and no specific sterility or storage instructions are provided beyond general surgical practice. The Klockner Kits hold an FDA 510(k) clearance under the product code KCT, with the submission reviewed by the Orthopedic Devices Panel (HO) and classified as substantially equivalent to a predicate device. No CE marking or additional regulatory authorisations are stated in the provided data.

Devices cleared under K243128

13 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K243128
UDI-DISize and differences
KLOCKNER KIT MEDGUIDE
SOADCO, S.L.
KIT MEDGUIDE / KIT MEDGUIDE08435451636164 —On the market
KLOCKNER KIT MEDGUIDE
SOADCO, S.L.
KIT MEDGUIDE / KIT MEDGUIDE08435451636614 —On the market
KLOCKNER KIT MEDGUIDE
SOADCO, S.L.
KIT MEDGUIDE / KIT MEDGUIDE08435451615756 —On the market
KLOCKNER KIT WT ESSENTIAL
SOADCO, S.L.
KIT WT ESSENTIAL / KIT WT ESSENTIAL08435451695994 —On the market
KLOCKNER KIT WT ESSENTIAL
SOADCO, S.L.
KIT WT ESSENTIAL / KIT WT ESSENTIAL08435451608840 —On the market
KLOCKNER KIT WT INTERNA
SOADCO, S.L.
KIT WT INTERNA / KIT WT INTERNA08435451615718 —On the market
KLOCKNER KIT WT INTERNA
SOADCO, S.L.
KIT WT INTERNA / KIT WT INTERNA08435451637956 —On the market
KLOCKNER KIT WT SNIPER
SOADCO, S.L.
KIT WT SNIPER / KIT WT SNIPER08435451637963 —On the market
KLOCKNER KIT WT SNIPER
SOADCO, S.L.
KIT WT SNIPER / KIT WT SNIPER08435451615725 —On the market
KLOCKNER KIT WT SNIPER JSI
SOADCO, S.L.
KIT WT SNIPER JSI / KIT WT SNIPER JSI08435451615732 —On the market
KLOCKNER KIT WT SNIPER JSI
SOADCO, S.L.
KIT WT SNIPER JSI / KIT WT SNIPER JSI08435451637949 —On the market
KLOCKNER KIT WT VEGA
SOADCO, S.L.
KIT WT VEGA / KIT WT VEGA08435451637970 —On the market
KLOCKNER KIT WT VEGA
SOADCO, S.L.
KIT WT VEGA / KIT WT VEGA08435451615749 —On the market

Similar devices

Other devices filed under FDA product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

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