Jetsonic 2000
by Deldent Ltd.
510(k) K014245
Jetsonic 2000 is a medical device (FDA Class II; FDA product code KOJ, Airbrush) made by Deldent Ltd., cleared under FDA 510(k) K014245 on 29 Jan 2002, 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 | FDA 510(k)SESE | NumberK014245 | Date29 Jan 2002 | StatusActive |
Official records
- FDA 510(k) database K014245
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KOJ
- FDA applicant
- Deldent , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6080
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K014245
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| JETSONIC 2000M HANDPIECE 533002 | 533002 / 533002 | 07290016281996 | — | On the market |
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