Johnson-Promident 505113
Johnson-Promident 505113 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 00840326403518), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840326403518 | Date24 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013969 | Date10 Jan 2002 | StatusActive |
Official records
- AccessGUDID record 00840326403518
- FDA 510(k) database K013969
Across registries
- FDA 510(k) K013969 decided 10 Jan 2002 Active
- FDA GUDID UDI-DI 00840326403518 listed 24 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K013969
- Listed FDA GUDID 00840326403518
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Johnson-Promident
- Generic name
- Dental abrasive air jet system handpiece
- Model / Ref / Catalog
- 505113
- Primary DI / UDI-DI
- 00840326403518
- 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
Similar devices
Other devices filed under FDA product code KOJ (AIRBRUSH).
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- MACH 7 by Kreativ, Inc.
- Powder Handpiece(For Perio use) by NAKANISHI INC.
- AEROETCHER by PARKELL, INC.
- AIR TECHNIQUES' AIRDENT II by Air Techniques, Inc.