Jetpolisher
by Deldent Ltd.
510(k) K014249
Jetpolisher is a Class II device made by Deldent Ltd., cleared under FDA 510(k) K014249 on 19 Feb 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 | NumberK014249 | Date19 Feb 2002 | StatusActive |
Official records
- FDA 510(k) database K014249
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- Withdrawn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 K014249
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 | |||
|---|---|---|---|---|
| Henry Schein 1026937 | 1026937 / 1026937 | 00304040108963 | On the market | |
| Henry Schein 9004171 | 9004171 / 9004171 | 00304040007433 | Weight 1770 g | On the market |
| Henry Schein 9004192 | 9004192 / 9004192 | 00304040007464 | Weight 83 g | On the market |
| Henry Schein 9004193 | 9004193 / 9004193 | 00304040007471 | Weight 28 g | On the market |
| JETPOLISHER 2000 BORDEN 0.95 | 519210 / BORDEN 0.95 | 07290016281712 | On the market | |
| JETPOLISHER 2000 BORDEN 1.1 | 519200 / BORDEN 1.1 | 07290016281705 | On the market | |
| JETPOLISHER 2000 MIDWEST 0.95 | 519310 / MIDWEST 0.95 | 07290016281736 | On the market | |
| JETPOLISHER 2000 MIDWEST 1.1 | 519300 / MIDWEST 1.1 | 07290016281729 | On the market | |
| JETPOLISHER 2000 QD - K 0.95 | 519910 / QD - K 0.95 | 07290016281798 | On the market | |
| JETPOLISHER 2000 QD - K 1.1 | 519900 / QD - K 1.1 | 07290016281781 | On the market | |
| JETPOLISHER 2000 QD - WH 0.95 | 519610 / QD - WH 0.95 | 07290016281774 | On the market | |
| JETPOLISHER 2000 QD - WH 1.1 | 519600 / QD - WH 1.1 | 07290016281767 | On the market | |
| JETPOLISHER 2000 QD-S 0.95 | 519510 / QD-S 0.95 | 07290016281750 | On the market | |
| JETPOLISHER 2000 QD-S 1.1 | 519500 / QD-S 1.1 | 07290016281743 | On the market | |
| Johnson-Promident 519900 | 519900 / 519900 | 00816577023454 | On the market | |
| JP/JST/JS HANDPIECE BOOSTER | 509111 / BOOSTER | 07290016281804 | On the market | |
| JP/JST/JS HANDPIECE REGULAR | 509120 / REGULAR | 07290016281811 | On the market |