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Klockner 18 05 02

by Soadco, S.L.

Klockner 18 05 02 is a Class II device made by Soadco, S.L., cleared under FDA 510(k) K153098 on 8 Apr 2016 and listed in FDA GUDID since 14 Jul 2022 (UDI-DI 08435451604750), 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) K153098

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 Number08435451604750 UDI-DI Date14 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK153098 Date8 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153098 decided 8 Apr 2016 Active
  • FDA GUDID UDI-DI 08435451604750 listed 14 Jul 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153098
  2. Listed FDA GUDID 08435451604750

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  • Withdrawn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
Intramucosal dental implant
Model / Ref / Catalog
18 05 02
Primary DI / UDI-DI
08435451604750
510(k) Number
FDA product code
NHA
GMDN term
Intramucosal dental implant
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Intramucosal dental implant

Cleared under the same submission (K153098)

and 8 more cleared under K153098

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)