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MB coupling Midwest 505111

by Deldent Ltd.

MB coupling Midwest 505111 is a Class II device made by Deldent Ltd., cleared under FDA 510(k) K013969 on 10 Jan 2002 and listed in FDA GUDID since 22 Nov 2022 (UDI-DI 07290016281026), 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) K013969

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 Number07290016281026 UDI-DI Date22 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013969 Date10 Jan 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013969 decided 10 Jan 2002 Active
  • FDA GUDID UDI-DI 07290016281026 listed 22 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013969
  2. Listed FDA GUDID 07290016281026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MB coupling Midwest
Generic name
Chairside dental abrasive air jet system
Model / Ref / Catalog
505111
Primary DI / UDI-DI
07290016281026
510(k) Number
FDA product code
KOJ
GMDN term
Chairside dental abrasive air jet system
Device class
Class II
Regulation number
872.6080
GUDID distribution status
In Commercial Distribution

Other devices from Deldent Ltd.

See all devices from Deldent Ltd. →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)