Johnson-Promident 505000
by Young Dental Manufacturing I, LLC
Johnson-Promident 505000 is a dental abrasive air jet system handpiece (FDA Class II; FDA product code KOJ, Airbrush) made by Young Dental Manufacturing I, LLC, cleared under FDA 510(k) K013969 on 10 Jan 2002 and listed in FDA GUDID since 12 Apr 2024 (UDI-DI 00816577020347), active as of 22 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 | Number00816577020347 | Date12 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013969 | Date10 Jan 2002 | StatusActive |
Official records
- AccessGUDID record 00816577020347
- FDA 510(k) database K013969
Across registries
- FDA 510(k) K013969 decided 10 Jan 2002 Active
- FDA GUDID UDI-DI 00816577020347 listed 12 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K013969
- Listed FDA GUDID 00816577020347
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- Withdrawn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
- 505000
- Primary DI / UDI-DI
- 00816577020347
- 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
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