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Klockner 10 05 14 G

by Soadco, S.L.

Klockner 10 05 14 G is a Class II device made by Soadco, S.L., cleared under FDA 510(k) K122988 on 19 Jul 2013 and listed in FDA GUDID since 14 Jul 2022 (UDI-DI 08435451600653), 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) K122988

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 Number08435451600653 UDI-DI Date14 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK122988 Date19 Jul 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122988 decided 19 Jul 2013 Active
  • FDA GUDID UDI-DI 08435451600653 listed 14 Jul 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122988
  2. Listed FDA GUDID 08435451600653

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  • Withdrawn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
10 05 14 G
Primary DI / UDI-DI
08435451600653
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 (K122988)

and 8 more cleared under K122988

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)