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Klockner 9631

by Soadco, S.L.

Klockner 9631 is a Class II device made by Soadco, S.L., cleared under FDA 510(k) K010132 on 4 Jun 2002 and listed in FDA GUDID since 23 Feb 2023 (UDI-DI 08435451611680), 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) K010132

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 Number08435451611680 UDI-DI Date23 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010132 Date4 Jun 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010132 decided 4 Jun 2002 Active
  • FDA GUDID UDI-DI 08435451611680 listed 23 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010132
  2. Listed FDA GUDID 08435451611680

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  • Withdrawn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
Overdenture
Model / Ref / Catalog
9631
Primary DI / UDI-DI
08435451611680
510(k) Number
FDA product code
NHA
GMDN term
Overdenture
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Overdenture

Cleared under the same submission (K010132)

and 8 more cleared under K010132

Similar devices

Also classified as Overdenture.

Similar devices

Other devices filed under FDA product code NHA (Abutment, implant, dental, endosseous).

Other devices from Soadco, S.L.

See all devices from Soadco, S.L. →

Properties

  • Sterilise before use
  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)