Skip to content

MB Quick coupling Sirona 505114

by Deldent Ltd.

MB Quick coupling Sirona 505114 is a chairside dental abrasive air jet system (FDA Class II; FDA product code KOJ, Airbrush) 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 07290016281057), 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 Number07290016281057 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 07290016281057 listed 22 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013969
  2. Listed FDA GUDID 07290016281057

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MB Quick coupling Sirona
Generic name
Chairside dental abrasive air jet system
Model / Ref / Catalog
505114
Primary DI / UDI-DI
07290016281057
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

Related devices

Category: Dental abrasive air jet system

Cleared under the same submission (K013969)

and 8 more cleared under K013969

Similar devices

Other devices filed under FDA product code KOJ (Airbrush).

Other devices from Deldent Ltd.

See all devices from Deldent Ltd. →

Properties

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