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Johnson-Promident 505105

by Young Innovations, Inc.

Johnson-Promident 505105 is a dental abrasive air jet system handpiece (FDA Class II; FDA product code KOJ, Airbrush) made by Young Innovations, Inc., cleared under FDA 510(k) K013969 on 10 Jan 2002 and listed in FDA GUDID since 24 Nov 2022 (UDI-DI 00816577020361), active as of 22 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 22 Oct 2026

Documents

510(k) K013969

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816577020361 UDI-DI Date24 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 00816577020361 listed 24 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013969
  2. Listed FDA GUDID 00816577020361

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Johnson-Promident
Generic name
Dental abrasive air jet system handpiece
Model / Ref / Catalog
505105
Primary DI / UDI-DI
00816577020361
510(k) Number
FDA product code
KOJ
GMDN term
Dental abrasive air jet system handpiece
Device class
Class II
Regulation number
872.6080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental abrasive air jet system handpiece

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 Young Innovations, Inc.

See all devices from Young Innovations, Inc. →

Properties

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