Disposable Prophy Angle
FDA 510(k) clearance K240950 · decided 2025-05-28
Clearance details
- K-number
- K240950
- Device name
- Disposable Prophy Angle
- Applicant
- Pacific Care Limited
- Decision
- Substantially Equivalent
- Date received
- 2024-04-08
- Decision date
- 2025-05-28
- Days to decision
- 415 days
- Clearance type
- Abbreviated
- Product code
- EGS
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- N.T., HK
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (K251869) | Premium Plus (Dongguan) Limited | 2025-09-15 |
| Star E900 Handpiece Series (K240183) | Dentalez, Inc., Stardental Division | 2024-09-19 |
| General Cutting Straight (K230106) | Nakanishi, Inc. | 2023-05-24 |
| FX Contra (K222518) | Nakanishi, Inc. | 2022-11-17 |
| Smooth Drive contra angle and straight handpieces (K220874) | Lares Research | 2022-11-07 |
| Lotus Prophy Angle (K220346) | Ajk Engineering, Inc. | 2022-11-07 |
| Dental Handpiece, Model CA160, CA160L, and CA500L (K220577) | Micro-Nx Co., Ltd. | 2022-07-29 |
| SURGmatic S15 L Pro (K213139) | Kavo Dental GmbH | 2021-12-21 |
| General Cutting Contra Handpiece (K202960) | Nakanishi, Inc. | 2020-10-27 |
| TRAUS Dental Handpieces (K182892) | Saeshin Precision Co., Ltd. | 2019-11-26 |
| General Cutting Contra Handpiece (K182999) | Nakanishi, Inc. | 2019-04-16 |
| STRONG Dental Handpieces (K181129) | Saeshin Precision Co., Ltd. | 2019-01-31 |
Recalls involving this device
No recalls on record reference this clearance.