Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
FDA 510(k) K251869 · Premium Plus (Dongguan) Limited
510(k) numberK251869
Submission
- Device name
- Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
- Applicant
- Premium Plus (Dongguan) Limited
Dongguan, CN - Received
- June 18, 2025
- Decision date
- September 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240950 | Disposable Prophy AngleEGS · Abbreviated | Pacific Care Limited | 05/28/2025SE |
| K240183 | Star E900 Handpiece SeriesEGS · Traditional | Dentalez, Inc., Stardental Division | 09/19/2024SE |
| K230106 | General Cutting StraightEGS · Traditional | Nakanishi, Inc. | 05/24/2023SE |
| K222518 | FX ContraEGS · Traditional | Nakanishi, Inc. | 11/17/2022SE |
| K220874 | Smooth Drive contra angle and straight handpiecesEGS · Traditional | Lares Research | 11/07/2022SE |
| K220346 | Lotus Prophy AngleEGS · Traditional | Ajk Engineering, Inc. | 11/07/2022SE |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional | Micro-Nx Co., Ltd. | 07/29/2022SE |
| K213139 | SURGmatic S15 L ProEGS · Traditional | Kavo Dental GmbH | 12/21/2021SE |
| K202960 | General Cutting Contra HandpieceEGS · Special | Nakanishi, Inc. | 10/27/2020SE |
| K182892 | TRAUS Dental HandpiecesEGS · Traditional | Saeshin Precision Co., Ltd. | 11/26/2019SE |
More from Saeshin Precision Co., Ltd.
Questions and answers
When was Disposable Prophy Angle (3399-60, 3399-090, 3399-105) cleared by the FDA?
Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (K251869) received a 510(k) decision of Substantially Equivalent on September 15, 2025, 89 days after the submission was received.
What is the product code of K251869?
The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.