Lares Research AS-1 Lowspeed Handpiece
FDA 510(k) K961163 · Lares Research, Inc.
510(k) numberK961163
Submission
- Device name
- Lares Research AS-1 Lowspeed Handpiece
- Applicant
- Lares Research, Inc.
Chico, CA, US - Received
- March 22, 1996
- Decision date
- April 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EFB
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| K251389 | High speed air turbine handpieceEFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…EFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional | W&H Dentalwerk Bürmoos GmbH | 02/28/2025SE |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 11/13/2024SE |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional | Foshan Soco Precision Instrument Co., Ltd. | 11/12/2024SE |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional | Nakanishi, Inc. | 09/20/2024SE |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional | Litu Tech , Ltd. | 04/30/2024SE |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional | Nakanishi, Inc. | 04/25/2024SE |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/22/2023SE |
| K232243 | EVO 700 series high speed handpieceEFB · Special | Ttbio Corp. | 08/23/2023SE |
More from Ttbio Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K220873 | Perceptive electric dental motor and control unitEIA · Traditional | 12/15/2022SE |
| K220874 | Smooth Drive contra angle and straight handpiecesEGS · Traditional | 11/07/2022SE |
| 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 |
| 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 Lares Research AS-1 Lowspeed Handpiece cleared by the FDA?
Lares Research AS-1 Lowspeed Handpiece (K961163) received a 510(k) decision of Substantially Equivalent on April 23, 1996, 32 days after the submission was received.
What is the product code of K961163?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.