Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)
FDA 510(k) K990682 · Nsk Nakanishi, Inc.
510(k) numberK990682
Submission
- Device name
- Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)
- Applicant
- Nsk Nakanishi, Inc.
Tochigi-Ken, JP - Received
- March 3, 1999
- Decision date
- March 24, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261987 | Reusable SmartPegEKX · Traditional | Osstell AB | 09/08/2026SE |
| K252223 | Alpha Endo Handpiece (Alpha Endo)EKX · Traditional | Shenzhen Superline Technology Co., Ltd. | 10/16/2025SE |
| K251597 | InnerView SystemEKX · Traditional | Perimetrics, Inc. | 09/18/2025SE |
| K243692 | EnDrive (EnDriveUS)EKX · Traditional | Advanced Technology Research (A.T.R.) S.R.L. | 08/22/2025SE |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)EKX · Traditional | Shenzhen Rogin Medical Co., Ltd. | 04/24/2025SE |
| K241065 | ChecQ (AC100)EKX · Traditional | Dentis Co., Ltd. | 03/21/2025SE |
| K243911 | HPR Cordless Hygiene HandpieceEKX · Traditional | Handpiece Headquarters | 12/20/2024SE |
| K222688 | The TrustEKX · Traditional | Genoss Co., Ltd. | 08/09/2024SE |
| K233865 | X-Smart Pro; X-Smart Pro+EKX · Traditional | Dentsply Sirona, Inc. | 07/24/2024SE |
| K232551 | EM-07 Cordless Endo MotorEKX · Traditional | Forum Engineering Technologies (96) , Ltd. | 07/09/2024SE |
More from Forum Engineering Technologies (96) , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K991701 | Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma Mu (Mini Head), Mach-Sigma Su (Std.…EFB · Traditional | 08/10/1999SE |
| K991021 | Sonic Scaler with Fiber Optic, Model Nas-L, Sonic Scaler Without Fiber Optic, Model Nas-NlELC · Traditional | 06/23/1999SE |
| K990954 | Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 SetEBW · Traditional | 06/09/1999SE |
| K990646 | Portable Electric Motor-Handpiece Unit, Handy-MateEKX · Traditional | 03/19/1999SE |
| K980162 | Mach-Sigma Handpiece, UltrapushEFB · Traditional | 06/05/1998SE |
| K972924 | Surgic II Implant Control UnitEBW · Traditional | 10/30/1997SE |
| K972569 | E-Type Speed Increaser Contra Angle, External Irrigation, Internal IrrigationEGS · Traditional | 10/08/1997SE |
| K971774 | NSK Push-Button Midwest Replacement Turbine:For Quietair and TraditionEFB · Traditional | 06/20/1997SE |
| K970953 | E-Type Speed Reducer Contra AngleKMW · Traditional | 04/15/1997SE |
| K962542 | Air Motor Handpiece TN-102EFB · Traditional | 09/24/1996SE |
Questions and answers
When was Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.) cleared by the FDA?
Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.) (K990682) received a 510(k) decision of Substantially Equivalent on March 24, 1999, 21 days after the submission was received.
What is the product code of K990682?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.