Delsonic 2000
by Deldent Ltd.
510(k) K014238
Delsonic 2000 is a Class II device made by Deldent Ltd., cleared under FDA 510(k) K014238 on 24 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 | NumberK014238 | Date24 Jan 2002 | StatusActive |
Official records
- FDA 510(k) database K014238
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELC
- FDA applicant
- Deldent , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4850
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K014238
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 | |||
|---|---|---|---|---|
| Delsonic 2000 Scaler 115 V | 512200 / 115 V | 07290016281941 | — | On the market |
| Delsonic Scaler Insert No 1 Universal | 512050 / No 1 Universal | 07290016281903 | — | On the market |
| Delsonic Scaler Insert No 2 Universal round | 512052 / No 2 Universal round | 07290016281927 | — | On the market |
| Delsonic Scaler Insert No 3 Flat Horizontal | 512053 / No 3 Flat Horizontal | 07290016281934 | — | On the market |
| Delsonic Scaler Insert No 4 Perio | 512051 / No 4 Perio | 07290016281910 | — | On the market |
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