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Klockner 10 00 02

by Soadco, S.L.

Klockner 10 00 02 is a Class II device made by Soadco, S.L., cleared under FDA 510(k) K173642 on 2 Oct 2018 and listed in FDA GUDID since 22 Nov 2022 (UDI-DI 08435451600004), 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) K173642

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 Number08435451600004 UDI-DI Date22 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK173642 Date2 Oct 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173642 decided 2 Oct 2018 Active
  • FDA GUDID UDI-DI 08435451600004 listed 22 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173642
  2. Listed FDA GUDID 08435451600004

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  • Withdrawn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
10 00 02
Primary DI / UDI-DI
08435451600004
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 (K173642)

and 8 more cleared under K173642

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)