Smooth Drive contra angle and straight handpieces
FDA 510(k) K220874 · Lares Research
510(k) numberK220874
Submission
- Device name
- Smooth Drive contra angle and straight handpieces
- Applicant
- Lares Research
Chico, CA, US - Received
- March 25, 2022
- Decision date
- November 7, 2022
- 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 |
|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105)EGS · Traditional | Premium Plus (Dongguan) Limited | 09/15/2025SE |
| 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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K220873 | Perceptive electric dental motor and control unitEIA · Traditional | 12/15/2022SE |
| K141221 | Lares Ultralite Prostyle High-Speed Dental Handpieces, Lares Euro Prostyle High-Speed…EFB · Abbreviated | 10/28/2014SE |
| K031540 | Apex Electric Handpiece SystemEKX · Traditional | 06/30/2003SE |
| K011960 | Lares Research Sunlase 800P Laser System (to Be Sold AS Pocketpro or Pocketpro S4)GEX · Traditional | 12/21/2001SE |
| K983524 | Lares Research Sunlase 800P Laser System (to Be Sold AS Peiolase for Laserenap)GEX · Traditional | 04/01/1999SE |
| K961163 | Lares Research AS-1 Lowspeed HandpieceEFB · Traditional | 04/23/1996SE |
| K905543 | Lares Apollo Cs/Cp/CEBZ · Traditional | 03/11/1991SE |
| K905542 | Lares Apollo CS and S Handpiece Lighting SystemsEFB · Traditional | 03/11/1991SE |
| K905541 | Lares 757 Workhorse Highspeed HandpieceEFB · Traditional | 03/07/1991SE |
Questions and answers
When was Smooth Drive contra angle and straight handpieces cleared by the FDA?
Smooth Drive contra angle and straight handpieces (K220874) received a 510(k) decision of Substantially Equivalent on November 7, 2022, 227 days after the submission was received.
What is the product code of K220874?
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.