Alpha Air Handpiece, Ultra-Push, Al-Su, Al-Mu, Al-Tu
FDA 510(k) K962543 · Nsk Nakanishi, Inc.
510(k) numberK962543
Submission
- Device name
- Alpha Air Handpiece, Ultra-Push, Al-Su, Al-Mu, Al-Tu
- Applicant
- Nsk Nakanishi, Inc.
Tochigi-Ken, JP - Received
- June 28, 1996
- Decision date
- September 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K242179 | Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional | W&H Dentalwerk Bürmoos GmbH | 02/28/2025SE |
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| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional | Foshan Soco Precision Instrument Co., Ltd. | 11/12/2024SE |
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| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional | Nakanishi, Inc. | 04/25/2024SE |
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|---|---|---|
| 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 |
| K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)EKX · Traditional | 03/24/1999SE |
| 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 |
Questions and answers
When was Alpha Air Handpiece, Ultra-Push, Al-Su, Al-Mu, Al-Tu cleared by the FDA?
Alpha Air Handpiece, Ultra-Push, Al-Su, Al-Mu, Al-Tu (K962543) received a 510(k) decision of Substantially Equivalent on September 11, 1996, 75 days after the submission was received.
What is the product code of K962543?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.